What's New in 25R3

Prerelease Date: November 3, 2025 | Release Date: November 21, 2025 & December 5, 2025

---

We are pleased to bring you Vault 25R3. Read about the new features below. You can find information on enabling new features in 25R3 Release Impact Assessment. Information on developer features (API, VQL, etc.) is in the Developer Portal.

Platform

Highlights

A summary of the major highlights for Vault Platform are displayed below, with further information accessible from the links. The rest of the Vault Platform release notes are then categorized into thematic areas, with the minor enhancements available in the final section.

To see demos for some of these key features and to read knowledge articles about other core platform functionality, join the Vault Platform community on Veeva Connect.

Feature	Description
Process Monitor	Process Monitor is a powerful new analytics tool designed to help business process owners and leadership streamline processes and improve key metrics. It provides visual insights into process flows, using built-in metrics and charts for KPIs like cycle time and volume, to help users identify bottlenecks and measure the impact of changes.
Improved Multi-Vault User Experience	Users can now more easily work across multiple Vaults at the same time without being logged out when switching Vaults.
Log In As for Administrators	Admins can now more easily log in as end users to help troubleshoot end user questions and issues.
Session Duration by Security Policy	Admins can now define variable session durations for users on a given domain by overriding the domain default in security policies.
Asynchronous Workflow Tasks	Workflows can now be configured to allow asynchronous job tasks that ensure the workflow only proceeds when the job is completed.
Bulk Support for Document Text Export	Admins can now extract text from documents using Vault Loader, building on recent enhancements to the Vault API.
Document Relationships Administration Page	Admins can self-administer a Vault’s document relationships and each relationship’s settings.
Label Sets	Users can now be shown alternative labels in the Vault UI within a single language, supporting scenarios where different groups within a given country or region may use varying terminology.
Standard User Layout	Admins can now leverage a new standard layout for users that takes advantage of recent layout enhancements.

Process Monitor

This release introduces a powerful analytics tool to enable business process owners and leadership to streamline processes and improve key metrics. By providing visual insights into your processes, Process Monitor helps users identify bottlenecks and optimize process flows to increase efficiency. Process Monitor works out of the box to provide a full suite of metrics, charts, and graphical analysis tools for any active object lifecycle.

Built-in metrics and charts for KPIs related to cycle time, volume, and quality enable users to measure the direct impact of process changes, ensuring continuous improvement.

The process graph allows users to trace workflows and identify inefficiencies through a visualization of the steps (lifecycle states) and paths (state-to-state transitions) that records have taken. Users can filter this graph using the variants panel, which isolates the unique paths records have traveled, allowing users to focus improvement efforts on the most common or problematic workflows.

Process Monitor is automatically on for all application families except Clinical Data, CRM, and Align. Users who currently have the Create permission for dashboards will see the new Process Monitor page by default on the day of release.

Learn more about Process Monitor and view the Feature Spotlight on Veeva Connect.

Improved Multi-Vault User Experience

When users access different Vaults across different browser tabs and windows, Vault sessions will now remain active in all tabs if the user changes Vaults within a tab or window by using the Vault selector.

Prior to 25R3, if a user had logged in to Vault A in two tabs or windows, then used the Vault selector in one of the tabs to change from Vault A to Vault B, they were logged out from Vault A in the other tab or window.

This enhancement removes friction for users when they need to work simultaneously in multiple Vault environments.

View the Feature Spotlight on Veeva Connect.

Log In As for Administrators

Admins now have an option to log in as another user. This feature leverages the existing Delegate Access functionality, but provides a more streamlined experience for Admins, particularly for scenarios where they are troubleshooting end-user issues and questions.

The new Log In As action will be available from the Actions menu on User records:

Once selected, the Log In As dialog displays with a default Delegation End Date of seven days in the future.

If an active delegation already exists, the Delegation End Date defaults to 365 days in the future.

Using the Log In As action creates a Delegate Access assignment:

This action is available to Admins if:

• Enable Vault Level Delegate Access is enabled in the Vault
• Enforce strict delegation controls for Delegate Admin users is enabled

• The Admin has the Admin: Users: Delegate Admin permission in their permission set and permission to execute the Log In As object action on the User object
  • The standard System Administrator and Vault Owner security profiles will have these permissions by default

The Enforce strict delegation controls for Delegate Admin users setting is required to ensure that an Admin cannot increase their own privileges. If a user account has more permissions than the Admin, the Log In As action is unavailable. This validation is based on a comparison of all permission sets associated with the user (via security profile or user role), as well as the Domain Admin user setting.

As part of this enhancement, the limit on the number of delegated accounts a user can have access to has been raised from 25 to 100.

Learn more about Log In As a User and view the Feature Spotlight on Veeva Connect.

Session Duration by Security Policy

Admins now have an option to set the Session Duration per Security Policy, allowing users to have variable session durations depending upon their needs. For example, an external user with a Password Security Policy may be assigned a shorter Session Duration, while internal users who are office-based may be assigned a longer Session Duration.

This allows customers to ensure balance between security and user experience for different types of users in their Vault.

Session Duration is the default domain-level setting configured in Admin > Settings > Domain Settings:

When configuring Security Policies, Admins can choose to use the default Session Duration domain setting, or set a different option for Logout user after inactivity for that Security Policy:

The Session Duration set at the Security Policy level is enforced for all Vaults in a user’s domain. By default, all existing Security Policies will use Domain Default Duration for the Logout user after inactivity setting with 25R3 to ensure consistent behavior.

Learn more about Configuring Security Policies.

Asynchronous Workflow Tasks

A new workflow Job step allows Admins to configure workflows that automatically start an eligible Vault Job then wait for its completion before advancing to the next step. The workflow Job step enables seamless integration with long-running, asynchronous work by tightly coupling the start and completion of a Vault Job within a single workflow step.

Learn more about Configuring Object Workflows, Configuring Document Workflows, and Configuring Document Definitions, and view the Feature Spotlight on Veeva Connect.

Bulk Support for Document Text Export

Building on the Document Text API released in 25R2, Vault Loader now allows you to set an Include Text checkbox when exporting documents. This setting generates a text file (.txt) for documents extracted that contains their document text. This functionality is also supported using the Loader CLI and the Vault API.

Learn more about Creating & Updating Documents Using Vault Loader.

Document Relationships Administration Page

Admins can now directly configure Document Relationship settings, providing direct control on which relationships are configured and the specific settings for each relationship. Admin > Configuration > Document Setup now includes the Document Relationships page:

Within this page, Admins can view all document relationships and create new document relationship types:

Within a relationship, Admins can also adjust relationship-specific settings, such as filters, doc types, and version-specificity settings.

Prior to 25R2, these settings could only be changed by submitting Support tickets.

Permission to manage Document Relationships is controlled by a new Document Relationships option in the Admin tab of Permission Sets. This permission is granted automatically for the standard System Administrator and Vault Owner security profiles.

Learn more about Document Relationships.

Label Sets

Label Sets allow Admins to display alternative labels in the Vault UI within a single language to support use cases where different groups of users within a given country or region may have different terminology. Admins can set up new Label Sets in Admin > Configuration > User Interface > Label Sets:

Admins can create up to ten (10) Label Sets per language. Once a Label Set is created, Admins can define terminology using the Bulk Translation tool for any label in Field Labels:

Admins can use a new Label Set field on the User object to assign users who need to see labels defined in a Label Set:

Similar to translations, Label Sets are specific to the Vault UI, including Vault reports. Label Set labels are not supported in Vault Mobile, Vault API, Vault Loader, VQL, Vault Admin, Notification Templates, System Messages, User Account Emails, Configuration Migration packages, or the Audit Trail. Also, the following UI elements do not display Label Set labels: picklist values, object types, lifecycle states, and document types.

Learn more about Language & Region Settings and view the Feature Spotlight on Veeva Connect.

Standard User Layout

In 25R2, the User layout when viewing records from Users & Groups was updated to align the user interface with other objects in Vault and support full object layout functionality.

Building on this feature, Admins can now leverage a new standard User Layout that takes advantage of pages and layout rules to better organize the layout:

Like other standard layouts, an Admin can use the Save As function to create a copy of the standard layout and adjust as needed:

Learn more about Configuring Object Layouts and About the User & Person Objects.

Managing Documents

Post-Processing Support for PDFs with Security

Vault now renders any PDF source file that is not protected from viewing. By default, Vault does not apply post-processing on renditions that have security applied, such as applying an overlay or performing Optical Character Recognition (OCR), though this can be enabled via Rendition Profile.

Prior to this feature, there was inconsistency in how Vault handled rendering of protected PDFs depending on the source file protection and post-processing actions being performed.

A new Rendition Profile setting, Post-processing support for PDFs with security, replaces the existing Allow viewing and annotations of protected PDF files setting, which has been deprecated.

With the 25R2.3 and 25R2.4 limited releases, the new Post-processing support for PDFs with security setting is defaulted to unchecked, regardless of whether the deprecated Allow viewing and annotation of protected PDF files setting was checked.

When Post-processing support for PDFs with security is unchecked, Vault does not perform post-processing activities, such as OCR and application of overlays, on protected PDFs. During limited release, you may need to enable Post-processing support for PDFs with security if your Vault relied on the Allow viewing and annotation of protected PDF files setting for post-processing activities, such as OCR and overlays, on PDF files with security applied.

With the 25R3 general release, the new Post-processing for PDF files with security setting setting will be automatically enabled in every rendition profile for Vaults that had the deprecated Allow viewing and annotations of protected PDF files setting enabled in their default rendition profile.

With this approach, customers can now control how documents should be handled individually by applying different rendition profiles. For instance, if a document has an external digital signature and it is important that the signature remain valid in the rendition, a user could apply a rendition profile with the Post-processing support for PDFs with security box unchecked. For other documents, it may be more critical to maintain the OCR and apply an overlay, in which case a rendition profile can be applied that has the Post-processing support for PDFs with security box checked.

If the rendition profile being used has the Generate Vault Protected PDFs option checked, downloaded viewable renditions have Vault protection. If no Vault protection is defined in the rendition profile, then Vault protection in alignment with the source PDF is applied.

Additionally, this feature adds a new standard document field, File Security, which is displayed in the File Info section of the Information panel on the Doc Info pane. This new field makes it easy for users to see what type of security their source file has.

Learn more about Configuring Rendition Profiles and view the Feature Spotlight on Veeva Connect.

Managing Data

Adaptive Rich Text Editor

This feature optimizes rendering Rich Text editors on record detail pages by introducing a lightweight display mode. This mode hides formatting options and prioritizes displaying content only until a user interacts with it. This enhancement removes distractions and provides noticeable performance gains for customers with layouts containing ten or more Rich Text fields or sections.

Formulas Within Formulas

This feature allows Admins to reference formula fields from within other object formula fields, field default values, and validation rules.

Previously, reusing formula logic required Admins to copy the entire formula into multiple configurations, making complex formulas difficult to maintain. This enhancement simplifies formula management so that Admins can build and update reusable logic more efficiently.

When configuring a formula, formula fields on the current object are now available in the Fields list in the formula editor.

When a formula field contains another formula field, Vault resolves this as a single formula. All characters across all formula fields are counted towards the existing 3,900 character limit on formula fields.

Detect Duplicate Persons When Editing Records

The existing Duplicate Person Detection functionality has been extended to detect duplicates when existing Person records are edited.

Prior to 25R3, Vault only detected duplicates when Person records were created. Applying this detection to both creation and update of records helps further ensure that customers can better manage their Person directory and further reduce potential for duplication.

If a duplicate email address is identified while editing, Vault will display a message on the Email field:

If a potential duplicate is detected via other methods, such as an exact match of First Name and Last Name, Vault displays the Similar Records Found dialog box:

Vault will flag potential duplicates when a user is specifically editing a field defined in the Duplicate Match Rules:

For instance, based on the above settings, updating Email or First Name would trigger Vault to check for duplicates, but updating a Person’s Manager would not.

Learn more about Duplicate Person Detection.

Word Formatted Output: Field Label Syntax & Additional Tokens

To better support global organizations with users across various regions, a new syntax will be introduced to Word Formatted Outputs that allows field labels to be printed, not just field values.

Appending “label” to the field token instructs Vault to print the field’s label rather than its value. For example, in the image below, ${name__v;label} prints “Contract ID” instead of “CTR-01000”:

Importantly, this token uses translated labels where appropriate based on the Language of the user downloading the output. Prior to 25R3, field labels needed to be static in a Word formatted output template, which meant that global users would always see the outputs in a single language, or Admins would need to set up different templates for different languages.

The label token can be placed after a ${Rowset()} and before ${RepeatRow()}, ${RepeatTable()}, or the token to pull the field value:
${Rowset(projects__cr)}
${name__v;label}
${RepeatRow()}
${name__v}

New syntax is also available to display a user’s Language and Locale: ${user__sys.language__sys} and ${user__sys.locale__sys}.

Learn more about Managing Word Formatted Output Templates.

User Experience

New Locales

To better support global organizations, Vault will now include over 200 new Locale values. A user’s assigned Locale determines how dates and numbers are formatted in the Vault user interface, ensuring a familiar user experience. Supporting a wider range of Locale values reduces the potential that a user needs to be assigned a Locale that doesn’t match their standard localized formats for dates and numbers.

Learn more about Supported Locales.

Latest Document Version Links Available in Document Workflow Notification Template Tokens

A new notification template token is now available for multi-document workflows that will include the link to the latest version of the document to help users receiving notifications navigate directly to the latest document version.

The new token is labeled: ${multiDocDocumentsListLatestVersion} Workflow Documents for Latest Version, and is available for all envelope object based notification templates.

Email Available Task Owners in Automated Participant Groups

The Available Task Owners option is now available within the Email Participants action for participant groups that are automatically populated from roles, groups, or user reference fields.

Process Optimization

Action Triggers Support IsChanged Function

Action Triggers support the IsChanged() function to help users evaluate if fields have been modified so that Action Triggers are more efficient.

25R2 Update Trigger Best Practice

PriorValue($priority__c) != priority__c && priority__c = PicklistValue($priority__c, "high__c")

25R3 Update Trigger Best Practice

IsChanged($priority__c) && priority__c = PicklistValue($priority__c, "high__c")

ThisRecord Function Supports Setting Reference Field Value in Action Triggers

We’ve enhanced the Create Record and Update Records actions within Action Triggers to allow the use of the ThisRecord() function when setting a reference field value to the record on which the trigger is being executed. This update simplifies the process of linking a newly created record or an updated record to the record that triggered the action.

Action Trigger Operator Menu Displays All Operators

The operator menu in the context aware editor now displays the full list of all Vault formula operators by category and sorts the suggested operators at the top of the list.

Multiple User Reference Fields for Workflow Participant Groups

Workflow participant groups that use a user reference field to populate the group now support multiple user reference fields.

Analytics

Additional Relative Filters for Dates

When filtering on dates in reports, users now have additional relative filter options. These filter options allow for more dynamic filtering and reduce the need for users to adjust date filters on an ongoing basis.

The following new filter options are available:

• Today
• Yesterday
• Tomorrow
• Previous Week
• Current Week
• Next Week
• Is in the last full (years, quarters, weeks, months, or days)

Learn more about Using Report Filters.

Search Filters on Non-Primary Objects in Reports

The new Search filter (introduced in 25R1) for Rich Text and Long Text fields in reports is now available to use on all objects in a report. With the initial release of this feature in 25R1, the Search option was only available to use for fields on the primary object in the report.

With 25R2, this filter is available on Rich Text and Long Text fields on all related objects in a report:

Extending this feature to all objects provides users the flexibility to filter their results without needing to be concerned with the structure of their report type.

Learn more about Using Report Filters.

Enhanced Merge Cells in Multi-Pass Reports

When merging the cells in a multi-pass report, Vault now provides an additional option to only merge the cells if the cells are associated with the same primary record of the report view. This option is enabled by default when Enable merge cells with same value is selected.

Additionally, when exporting multi-pass reports with cell merging to PDF or formatted Excel, the exports now maintain the cell merging. If the report is included in a flash report, it also shows the merged cells in the email.

Learn more about Creating Reports and view the Feature Spotlight on Veeva Connect.

Descriptions & Footers on Dashboard Charts

Users can now add a description and footer to dashboard charts. These options are added to the formatting section of each chart and make it easier to understand the content of the chart.

Learn more about Creating & Editing Dashboards.

Dashboard Charts Drill Down Enhancement

When clicking into data from a dashboard chart, users are now taken to the relevant grouped data, rather than to the entire report. This enhancement improves the user experience and ensures that users can easily view more relevant details when using dashboards.

For example, if a user clicks on the Approved status in this chart:

Vault opens the underlying report already focused on the grouping of Approved documents:

Learn more about Viewing & Sharing Dashboards.

Support Ladder Multi-Pass Reports in Dashboards

Customers can now add reports with multi-pass ladder configuration to dashboards. They can be added to all chart types, and all chart functionalities are supported. A ladder multi-pass report is a report type that joins each secondary Report View directly back to the primary Report View:

Prior to 25R3, only chain multi-pass reports were supported for dashboards.

Learn more about Creating & Editing Dashboards.

Enhanced Standard Matrix Report

Standard matrix reports now support the use of report formula fields as well as the ability for users to determine which columns should be displayed when report viewers drill into details.

Columns that are added are displayed when a user clicks into a grouping:

This enhancement provides additional flexibility to ensure that users are able to get the right data in a matrix format.

Learn more about Matrix Reports.

Admin Experience

Migration Rendition Reuse for Office & PDFA Files

When migrating documents using the file staging server, renditions previously rendered in one Vault are now reused when migrating the same documents to other Vaults. For instance, if documents have already been loaded into a Sandbox environment, when migrating into a Test environment, Vault uses the existing renditions rather than re-rendering them in the Test environment. This specifically applies when a Vault’s file staging server is pointing to one other than its own.

Learn more about Creating & Updating Documents Using Vault Loader.

Outbound Email Domain: Delete Root Domain

When configuring Outbound Email Domains, users can now delete a root domain if it is not yet verified or if there are no Outbound Email Domains that use the root domain.

Vault Loader Support for Changing Object Type

Vault Loader now supports changing the Object Type of object records.

To avoid potential confusion, the UI label for Object Type has been renamed to Entity Type.

Learn more about Creating, Updating & Deleting Object Records Using Vault Loader.

Bulk-Cancel Jobs in Queued or Queueing State

Admins can now cancel in bulk certain jobs in the Queued or Queueing states from the Job Status > Running page. If there are jobs in the list that are not cancellable, they will not be cancelled.

Learn more about Managing Job Instances.

Customizable Timeout Period for SDK Jobs

Admins can now specify a timeout duration for custom SDK jobs in Admin > Operations > SDK Job Metadata. The default timeout duration is 23 hours for one-time jobs and 72 hours for recurring jobs. Adding a custom timeout duration is useful for recurring jobs with high recurrence frequencies or that have critical functionality because the default timeout duration of 72 hours may be too long.

Learn more about Administering SDK Job Metadata.

Permissions & Access

Delegate Access: Vault Owner Group Restriction

Admins can now better control delegation of Vault Owner accounts by using the Delegate access allowed only among group members option on the standard Vault Owners group:

Prior to 25R3, this option could be used to constrain delegate access on all groups except the standard Vault Owners group. By supporting this on the Vault Owners group, customers can prevent a Vault Owner from delegating their account to a user who is not a Vault Owner.

The ability to control delegation based on group membership is dependent on the group-level setting as well as a Vault-level setting:

Learn more about Restricting Delegate Access and view the Feature Spotlight on Veeva Connect.

Privilege Escalation for Security Policy Conversions

Vault will now prevent Admins from using the Convert Security Policy action on users who have more permissions than the Admin initiating the update. In these cases, the Convert Security Policy action will not display in the Actions menu.

For example, if one user has the standard System Administrator security profile:

They would not see the Convert Security Policy action on a user with the Vault Owner security profile:

Learn more about Converting User Security Policies.

Support for All Application Roles in Tree Security

Admins can now leverage all application roles with Tree Security. Prior to 25R3, only the standard Owner, Editor, and Viewer roles were supported for user tree assignments.

To enable this functionality, the Application Role field on new User Tree Assignment objects will no longer be constrained to these roles. Existing User Tree Assignment objects will maintain current behavior, though Admins can remove the constraints from the Application Role field:

If an object’s lifecycle does not support an application role assigned via a User Tree Assignment object, Vault ignores that assignment. If the application role is subsequently enabled on the object’s lifecycle, all user tree assignments referencing the application role are immediately applied.

Learn more about Security Tree Administration.

VeevaID: Enhanced Multi-Factor Authentication

VeevaID users will now be prompted for Multi-Factor Authentication (MFA) based on the user’s country, in addition to the existing MFA behavior in which Vault prompts for MFA once every 30 days.

Specifically, VeevaID will additionally initiate MFA when:

• A VeevaID user logs in from a new country
• A VeevaID user has two successful login attempts from two different countries within four hours

This enhancement increases the security measures for VeevaID by leveraging the existing MFA functionality in additional risky circumstances.

Learn more about Logging Into VeevaID.

Performance & Availability

Asynchronous Audit Exports

All exports from the Object Record Audit History, Document Audit History, and related record audit history are now asynchronous, regardless of size.

For these asynchronous reports, Vault sends a notification once exports are complete so that users and Admins can download the files.

This enhancement ensures that Vault is able to provide users with large audit history files while still allowing them to continue their work in Vault while the export is generated.

Audit exports on individual documents or object records (that do not include related records) continue to be exported synchronously.

Learn more about Viewing Audit Trails and Viewing Admin Logs.

Increase User Role Limits

A single user can now have up to 50 assigned user roles, increased from the prior limit of 15 per user. This enhancement provides customers with more flexibility in managing permissions granularly by allowing a larger number of distinct permission combinations to be assigned to a given user.

Report Export Limit Increase for Excel

This feature increases the maximum number of rows that can be included in a report export to Excel from 100,000 to 250,000 rows. This limit increase applies to report exports that use the Data Only, Formatted Excel, and Excel Templates formatting options.

Word Formatted Output: Object & Rowset Limit

Word formatted output templates now support referencing up to 40 unique object relationships, an increase from the prior limit of 30. Additionally, Word Formatted Outputs now include an overall Rowset() limit of 50. For instance, using ${Rowset(relationship__cr)} twice in a template would count once toward the unique object relationship limit of 40, and count twice towards the overall Rowset() limit of 50.

This enhancement provides more flexibility by increasing the relationship limit to 40 and only counting each object once, even if referenced multiple times, while still ensuring performance with the overall Rowset() limit.

There are no changes to existing limits for Adobe templates.

Learn more about Managing Word Formatted Output Templates.

Scheduled Data Exports: Entity Modification Limits

When modifying Scheduled Data Export configurations, the system enforces a strict limit of 30 entities. Customers with more than 30 entities in the configuration must remove entities until it is below the limit to save the changes.

Minor Enhancements

Support Created By & Last Modified By Fields in Report Formula Fields

Users can now add the Created By and Last Modified By fields in report formula fields. Admins and users can wrap these fields in Text() to retrieve the user’s name and Id() to retrieve the ID for the user.

Email Participants Notification Template Set to Every Occurrence

The Email Preferences value for the email_participants__v notification template is set to Every Occurrence when it was previously set to Summary. This value was previously set to Summary in 25R1, or 25R2 if customers opted out; however, based on customer feedback, it is preferable to immediately send this type of notification as soon as it occurs.

Learn more about Email & Messages Administration.

Notifications Suppressed in Migration Mode

To reduce unnecessary notifications, Vault will no longer send notifications if records or documents are created or updated using Vault Loader or the API with Record or Document Migration Mode enabled. While Vault does not notify users for record or document creations and updates by default, this type of behavior can be configured in various ways, such as through Event Actions, Entry Actions, or Action Triggers. Examples of these notifications include:

• Event Action that starts a workflow which sends a notification
• Entry Action that sends a notification when a record is updated
• Action Triggers or Vault Java SDK record triggers that send notifications when a record is created

Prior to 25R3, sending these notifications as configured created an unnecessary notification burden for users, and could impact the performance of the Vault overall.

Learn more about Record Migration Mode and Document Migration Mode.

Provide Additional Fields in Field Dependency Grid & Export

To make field dependencies more easily understandable, additional fields are now available in Admin > Configuration > Field Dependencies and the field dependencies Excel export file.

The Admin UI now shows the API Name of the field dependency, and the Excel export now contains the following additional columns:

• API Name
• Type of field dependency
• Controlling Field Type
• Controlling Field Label
• Controlling Field Name
• Controlled Field Type
• Controlled Field Label
• Controlled Field Name
• Behavior
• Role

Picklist Field Search Behavior Enhancements

When searching in picklist fields on objects, Vault will now treat searches as “starts with” rather than “contains”. This enhancement makes the picklist field search behavior consistent across Vault.

Prior to 25R3, searching picklist fields on documents or searching object picklist fields with over 100 values used “starts with” - only object picklists with less than 100 values used “contains”, which created an inconsistent user experience.

As an example, searching “Pur” or “Agree” will return the following types of results in this picklist:

However, searching “ment” would not return items with the term “Agreement”:

Label Limit Increases for Attachment & Workflow Timeline Sections

This feature applies the Section Help Content (255 characters increased to 500) and Section Label (40 characters increased to 150) limits to the Attachment and Workflow Timeline sections in object layouts.

Login Audit History: My Vaults Page

The Login Audit History now captures a new event, Enterprise User Home Login, when users authenticate into Vault and start their session on the My Vaults page. This enhancement improves clarity on the specific location users land on when logging in, allowing differentiation between a user logging in and landing in a particular Vault (logged as Vault Authentication) or landing on the My Vaults page (logged as Enterprise User Home Login).

Learn more about Login Audit History.

Retaining Sandbox Snapshots Enabled By Default

This feature, which allows Vault to provide an option to change the source of a Snapshot when deleting a Sandbox, is now enabled for all Vaults.

Hide Inactive Stages in UI

The Lifecycle Stage chevron UI will not display a stage when it is inactive and does not have any states configured for it.

Search Truncation Warning Update

When a full-text search is truncated due to a search term found in over 5,000 documents, the warning will now display on the Search Scope field. The warning will remain on screen until the user closes it.

Prior to 25R3, this warning was displayed as a temporary banner at the top of the browser window, which could lead to confusion for users if they did not see the banner. This feature helps ensure users do not miss the warning.

25R3 Platform Data Model Changes

With every release, we update the data model to better support evolving needs and new feature functionality.

Access the 25R3 data model documentation on Veeva Connect:

• Vault Platform
• Clinical Operations
• Commercial
• Quality
• Regulatory
• Safety
• Consumer Products

Veeva Connections

Clinical Operations-eCOA Connection

Clinical Operations-eCOA Connection: End of Study Media

The Clinical Operations-eCOA Connection has been enhanced to automatically transfer eCOA participant data end of study documents to the Clinical Operations Vault when those documents are generated or re-generated in eCOA for Studies that are connected between the Vaults.

Learn more about other new Clinical Operations features below.

Clinical Operations-EDC Connection

Clinical Operations-EDC Connection: CTMS Managed Protocol Deviations

This feature enhances the management of Protocol Deviations (PDs) that originate in EDC and are created in CTMS by the connection and managed within CTMS. This new functionality limits connection updates to connection created Protocol Deviations in CTMS to only specific fields on Protocol Deviation records to prevent overwriting information that has been updated within CTMS. The connection will now only update the Protocol Deviation Status in EDC and Deviation Date fields and will mark records as deleted if they are deleted in EDC. This ensures that the CTMS-managed records remain the single source of truth for Protocol Deviations and improves data integrity and oversight in CTMS. This feature applies to both Restricted and Unrestricted records.

Learn more about other new Clinical Operations features below.

Clinical Operations-EDC Connection: Prevent EDC Study Name Duplicates

With this feature, the connection will no longer update the Study label in EDC if the Study name is already used by an existing EDC study or study instance to avoid duplicate study names across EDC environments.

See the Release Note for the Clinical Operations - EDC Connection: Enforcing Unique Study Names feature in Veeva Clinical Data Help: New Features in 25R3 Limited Releases for more information.

Learn more about other new Clinical Operations features below.

Clinical Operations-EDC Connection: Auto-Create System Links

This feature automates Site System Link creation for Veeva EDC. When a Study is marked to use the EDC system, a link is automatically created, allowing Veeva ID site users to access it easily via Site Connect, reducing the administrative burden of manual link sharing for Sponsor/CROs.

Learn more about other new Clinical Operations features below.

eCOA-Clinical Operations Connection

eCOA-Clinical Operations Connection: Auto-Create System Links

This feature automates Site System Link creation for eCOA. When a Study is marked to use the eCOA system, a link is automatically created, allowing Veeva ID site users to access it easily via Site Connect, reducing the administrative burden of manual link sharing for Sponsor/CROs.

Learn more about other new Clinical Operations features below.

Medical-CRM Connection

Medical-CRM Connection: Metadata Sync Integration

This integration enables the distribution of CRM metadata for use with CLM, Approved Email, and Events Management over the standard Medical-CRM Veeva connection. The features built as part of this integration will support the new Content Supply Chain.

Learn more about the Medical-CRM Connection.

Learn more about other new Medical features below.

Medical-Quality Connection

Medical-Quality Connection: Transfer of Product Quality Complaints from Medical to Quality

This new Veeva connection allows customers to share potential Product Quality Complaints raised in Veeva Medical - MedInquiry with Veeva Quality - QMS.

In this connection, Product Quality Complaint records in MedInquiry are shared to QMS with required complaint and product information, where they are created as Complaint Intake records for investigation and reporting. After Complaint Intake creation, reconciliation information is shared from QMS back to MedInquiry. Further action on the Complaint Intake triggers Vault to share Complaint information from QMS back to MedInquiry, including the Complaint Number(s).

Learn more about the Medical-Quality Connection.

Learn more about other new Medical features below.

Medical-Safety Connection

Medical-Safety Connection: Performance Enhancements

With this release, Event Product and Event Reaction records under an Event that has already been transferred to Safety cannot be edited. In addition, the connection now schedules a new pull from Veeva Safety if the Last Successful Run Time on the Adverse Event Integration record is modified.

Learn more about other new Medical and Safety features below.

PromoMats-CRM Connection

PromoMats-CRM Connection: Metadata Sync Integration

The integration enables the distribution of CRM metadata for use with CLM, Approved Email, and Events Management over the standard PromoMats-CRM Veeva connection. The features built as part of this integration will support the new Content Supply Chain.

Learn more about the PromoMats-CRM Connection.

Learn more about other new Commercial features below.

PromoMats-CRM Connection: Product Data Transfer

The new Veeva connection for PromoMats-CRM supports the automatic transfer and alignment of Product and Indication data across these application families. Product Family, Brand, and Indication are transferred from Vault PromoMats to Vault CRM. This eliminates the potential for user errors when manually recreating these records in Vault CRM.

Learn more about other new Commercial features below.

Quality-RIM Connection

Quality-RIM Connection: Requires Correction State for Change Item

This release introduces an enhancement to the Quality-RIM Connection that provides a new feedback loop for the Enhanced Change Control process. During the regulatory assessment step in RIM, users can now formally notify the Quality team that corrections are needed on a Change Control before the assessment is completed. This ensures that issues, such as a missing Product Variant, are resolved efficiently within the system, creating a clear audit trail of the correction process.

The feature introduces a new two (2)-step workflow managed by two (2) new lifecycle states:

1. Requesting a Correction (RIM-to-Quality):
   • A Regulatory user in the RIM Vault, while a Change Item is in the In Assessment state, identifies an issue.
   • They change the Change Item state to the new Requires Correction state.
   • Details of the required changes are entered into the new Correction Details text field.
   • The connection automatically updates the corresponding Regulatory Change Item in the Quality Vault to the Requires Correction state and syncs the details.
2. Confirming a Correction (Quality-to-RIM):
   • The Quality team is notified and makes the necessary updates to the Change Control.
   • Once complete, a QMS user changes the Regulatory Change Item state to the new Corrected state.
   • The connection notifies RIM, and the Change Item in the RIM Vault is automatically updated to the Corrected state. Should a Quality user identify an issue while the Regulatory Change Item is in the In Assessment state, they can also make the correction directly to the Regulatory Change Item and update its state to Corrected.
   • The Regulatory user can now proceed with their assessment of the corrected item.

Key Benefits

• Improved Communication: Formalizes the feedback process between Regulatory and Quality teams.
• Increased Efficiency: Reduces delays by clearly flagging items that need correction without manual follow-up.
• Enhanced Compliance: Creates a clear, traceable history of corrections within the change control record.

Important Considerations

• This feature reuses existing connection points and does not require new integration rules, but relies on filters on the existing rules. The new states do not apply to Activity Change Item or Regulatory Activity Item records.
• Configuration is required to enable this feature.

Learn more about other new Quality and Regulatory features below.

Quality-Safety Connection

Quality-Safety Connection: Follow-Up & Single Intake Creation Logic

We’ve enhanced the Product Quality Complaint (PQC) connection between Quality and Safety Vaults to deliver faster, more accurate processing of PQCs with less manual effort. This update improves the handling of PQCs received by a Quality Vault from the source Safety Vault by reducing the number of Complaint Intakes initially created and automatically identifying follow-up Complaint Intake records.

Additionally, Safety Case Assessment records promoted to the Quality Vault will see the following improvements:

• Richer data regarding products: Vault now flags Complaints from the connection if they represent a combination device and pharmaceutical product as part of their context by capturing Reported Product information directly from the Safety Case as record relationships in the Quality Vault. This reduces the amount of back-and-forth between Quality and Safety teams during Complaints processing.
• Smarter follow-up processing: Follow-ups are automatically tagged and linked to the existing initial Complaint Intake and any applicable Complaints associated with the Complaint Intake. This automation eliminates the need for Quality users to manually identify and mark up new Complaint or Complain Intake records from the connection as follow-ups to existing records, which improves processing speed and accuracy.
• Clearer traceability to Case Assessments: We’re introducing the Safety Case Assessment object to Quality Vaults to ensure that the Quality Vault creates only the required number of Complaint Intake records, even if there are many Case Assessments in the Safety Vault that result in those Complaint or Complaint Intake records, and that the Quality team has visibility into all appropriate Case Assessments from the Safety team.

Together, this functionality works to ensure that Quality and Safety teams can work together more seamlessly in their core competencies, with higher quality data, for faster, more accurate Case and Complaint processing, resulting in fewer records.

Learn more about the Quality-Safety Connection.

Learn more about other new Quality and Safety features below.

Quality-Safety Connection: Provision Standard Product Family & Variant Field Rules

This feature introduces new fields to capture Product Family and Product Variant information in support of organizations accepting Complaint Intakes and Product Quality Complaints (PQCs) from a Safety Vault via the Quality-Safety PQC Integration.

With this release, when an organization receives a new or updated PQC from a Safety Vault via the Transfer PQCs to Quality action, in addition to creating Reported Product records by copying over Product information, the Quality Vault will now search for matches to any Product Family or Variant information present in the Case record in the Safety Vault.

Any exact matches will be populated on the Complaint Intake and PQC, which provides higher fidelity information to the Quality business teams without the need for manual communication to the Safety teams. Product, Product Family, and Product Variant information will be independently sourced and matched on the Reported Product records based on the data available in the Safety Vault. This means that cases like Combination Products, where a Safety Vault does not include Product Variant information, will still be brought over to the Quality Vault appropriately with the Product and Product Family information preserved.

These matches are based on the population of the link__sys field of the Product Family and Product Variant records in both the Quality Vault and Safety Vault. If no exact match is found, no data will be copied over to that field in the PQC. This functionality is supported both for initial and follow-up Case > PQC transfers from a Safety Vault to a Quality Vault.

Learn more about the Quality-Safety Connection.

Learn more about other new Quality and Safety features below.

RIM-Clinical Operations Connection

RIM-Clinical Operations Connection: Updates to Submission Tracking for Clinical Trials

The RIM-Clinical Operations Connection streamlines regulatory tracking by bridging RIM Vault and Clinical Operations Vault. Since 25R2, the Connection automatically transfers key regulatory approval information, including submission dates and verdicts, from RIM objects to Clinical milestones, preventing double-entry and ensuring data integrity for global initial clinical trial approvals like EU CTR.

While the Connection successfully streamlines regulatory data flow, it is crucial to recognize that Ethics Committee/Institutional Review Board (EC/IRB) approvals and EU Clinical Trials Regulation (EU CTR) final country approvals represent distinct and separate regulatory processes. This inherent difference demands a clear distinction in how these critical milestones are tracked within Veeva Vault. Using the EC/IRB Approval milestone for EU CTR has created challenges for consistent and accurate data tracking, leading some customers to use custom milestones as a workaround.

This new feature introduces an update to the Connection that supports transferring key dates and data to a new standard Final Country Approval milestone. This milestone is specifically designed for EU CTR, replacing the previous use of the EC/IRB Approval milestone for these trials. This change ensures standardized and comprehensive tracking of critical regulatory information within Veeva Clinical Vaults.

Learn more about other new Regulatory and Clinical Operations features below.

RTSM-Clinical Operations Connection

RTSM-Clinical Operations Connection: Auto-Create System Links

This feature automates Site System Link creation for RTSM. When a Study is marked to use the RTSM system, a link is automatically created, allowing Veeva ID site users to access it easily via Site Connect, reducing the administrative burden of manual link sharing for Sponsor/CROs.

Learn more about other new Clinical Operations features below.

Safety-Clinical Operations Connection

Safety-Clinical Operations Connection: Match Countries Based on Code

With this release, the Safety-Clinical Operations Connection uses the Country Code values to map Countries between Clinical Operations and Safety Vaults when populating Country of Origin in Clinical Operations Vaults. Previously, Country Names had to exactly match between Vaults.

Learn more about other new Safety and Clinical Operations features below.

Safety-Clinical Operations Connection: New Integration Field Rule

With this release, the Safety-Clinical Operations Connection includes a new field rule for the Study Design Type field on the Study object in Clinical Operations Vaults. This rule is inactive in all Vaults.

Learn more about other new Safety and Clinical Operations features below.

Safety-Clinical Operations Connection: Setting Product in Clinical Operations

With this release, the Safety-EDC Connection now populates the Product field in Crosslink documents generated in Clinical Operation Vaults based on Safety Letter and Cover Letter distribution data transferred from the Safety Vault.

If you’re interested in discussing whether getting early access to this feature is appropriate for your business needs, contact your Veeva Representative.

Learn more about other new Safety and Clinical Operations features below.

Safety-EDC Connection

Safety-EDC Connection: Improvements for Mapping, Merging & Error Handling

This feature introduces several improvements to the Safety-EDC Connection, including:

• Mapping enhancements: A new EDC AESI field on the Case Adverse Event object maps to the CDMS Subject Adverse Event when users add Adverse Events when running the Add Relevant Subject Information action. Additionally, Admins can define custom Significance Criteria for the EDC AESI field, taking into account its value on both the Inbox Item and the Case.
• Error handling: When Inbox Item creation fails because the Organization of the Study or Transmission Profile is not of type Sponsor, Vault now displays a user warning to alert users of the issue.

Learn more about the Safety-EDC Connection.

Learn more about other new Safety features below.

Safety-EDC Connection: Improvements for Study Drug Mapping, Merging & Significance Criteria

With this release, Veeva introduces several improvements to the Safety-EDC Connection, including:

• Device and gestation mappings: New standard safety fields added to EDC Vaults for mapping to the Study Drug Safety Form Type, mapped to the respective Case Product fields in Safety Vaults:
  • Gestation Exposure Number
  • Gestation Exposure Unit
  • Device Name
  • Device Evaluated
  • Device Usage Type
  • Device Implanted Date
  • Device Explanted Date
  • Device Age
  • Device Age Unit
  • Additional Information Coded
• Inbox Item Significance Criteria: You can now check if a specific field value in an Inbox Item has changed relative to its corresponding Case and evaluate multiple Inbox Item or Case values at once using logical operators such as OR (||) and AND (&&). This update allows for more sophisticated and flexible automation, ensuring that only the most relevant items are flagged as significant.
• Merging behaviour in multi-event Cases: When you promote an Inbox Item to an existing multi-event Case, Vault creates a Case Identifier for the new event. This ensures each event within a multi-event Case is properly identified as a follow-up. Vault creates a new Case Identifier when the Link values differ on the Inbox Item and Case.
• Date and time for Date of Death: The Date of Death field now supports DateTime values instead of just Date values.
• Custom field mapping to Reason Omitted fields: Admins can now configure the connection to transfer custom Reason Omitted picklist field values so that Vault properly populates the value on the standard Reason Omitted field on Cases.

Learn more about other new Safety features below.

Safety-EDC Connection: Linking Parent & Child Case Information

With this release, the Safety-EDC Connection enhances Case-linking functionality for pregnancies and related Serious Adverse Events (SAEs) across parent, pregnancy, and child Case Adverse Events by automating the creation of Case record structures.

Key Enhancements:

• Child Casebook Creation: If the child of a trial participant experiences an SAE in the context of an unexpected pregnancy, EDC creates a dedicated Casebook for the child, linked to the parent Casebook.
• Automatic Case Linking: Vault links the child’s Case and the relevant pregnancy or adverse event Case in Safety using the Parent Subject Global ID field in EDC.
• Seamless Transfer: When a child’s Casebook is linked to the mother’s Casebook in EDC, this relationship transfers to Safety. The Safety Vault creates an appropriate parental Case linked to the child’s Case.
• Multiple Adverse Event Support: If multiple pregnancy or parent events exist, Vault links the most relevant prior Case to the child’s Case, ensuring accurate parent-child associations.

This feature streamlines the management of complex pregnancy scenarios by ensuring automatic and consistent parent-child Case linkage across EDC and Safety Vaults. It also enhances traceability, allowing for more reliable tracking of maternal and child safety data, ultimately improving oversight and efficiency in case handling.

Learn more about other new Safety features below.

Safety-RIM Connection

Safety-RIM Connection: Reflect Accurate Deletions in Safety Vaults

With this release, the Safety-RIM Connection improves join record deletion. When a Safety record is linked to multiple join records in RIM (such as those related to FDA code and MPID), Vault only clears the record’s associated fields when the most-recently synched join record is deleted in the RIM Vault.

Learn more about other new Safety and Regulatory features below.

Safety-RIM Connection: Transfer All Valid Registrations

With this release, the Safety-RIM Connection handles Registration data synchronization failures caused by agency-related validation issues by creating a User Exception Item (UEI) for the failed registration, and transfers all other valid Registrations. This prevents the connection from blocking entire Registration batches due to a single validation failure and ensures a smoother handling of failures.

To help identify and resolve issues quickly, Vault displays the following error messages:

• No Agency Assigned to Country: The selected country is not set up within the jurisdiction of any Agency. Assign an Agency to the country and try again.
• Inactive Agency: [Country] is set up within the jurisdiction of [Agency], which is inactive. Ensure [country] is assigned to an active Agency and try again.
• Missing Submission Ruleset: [Country] is set up within the jurisdiction of [Agency], which does not have Submission Rules. Assign a Submission Ruleset to [Agency] and try again.

Learn more about other new Safety and Regulatory features below.

Study Training-Clinical Operations Connection

Study Training-Clinical Operations Connection: Auto-Add Differentiated Security Profiles

This feature automates Security profile assignments for Users coming over from Clinical based on what’s determined in the new Security Profile Mapping object records (security_profile_mapping__v). This applies to new User record creation only.

Training Admin users are able to set up these mapping records in Study Training.

This allows Sponsor/CROs to leverage automated group permissions without manually updating the Security Profile for these users.

If a mapping for a Security Profile is not set up, the Study Training-Clinical Operations Connection will create users with the standard “Training User” Security Profile by default.

Learn more about other new Clinical Operations features below.

Study Training-Clinical Operations Connection: Auto-Sync Clinical User Status in Study Training

This feature ensures consistent treatment of user status across global directory by syncing a Clinical Operations user’s status with their Study Training user status. When a Clinical Operations User record Status changes to inactive or active, Vault updates their corresponding Study Training User record Status to match.

To facilitate this, a new User Integration (st_co_user_integration__v) is added to the Study Training to Clinical Operations Connection, along with a new Study Training ClinOps: User integration rule (st_co_user_ir__v) and related user_status__v field rule.

Synchronization is one-way only, from Clinical Operations to Study Training, and applies only to User records created or updated after this feature’s release.

Learn more about other new Clinical Operations features below.

Study Training-Clinical Operations Connection: Auto-Create System Links

This feature automates Site System Link creation for Study Training. When a Study is marked to use the Study Training system, a link is automatically created, allowing Veeva ID site users to access it easily via Site Connect, reducing the administrative burden of manual link sharing for Sponsor/CROs.

Learn more about other new Clinical Operations features below.

Clinical Operations

In addition to the below release notes, the CTMS, eTMF, Veeva Site Connect, Study Startup, Payments, and Study Training Veeva Connect communities offer general release communications, release highlights, and key feature demos.

The following features listed in the Veeva Connections section also affect the Clinical Operations application family:

• Clinical Operations-eCOA Connection: End of Study Media
• Clinical Operations-EDC Connection: Auto-Create System Links
• Clinical Operations-EDC Connection: CTMS Managed Protocol Deviations
• Clinical Operations-EDC Connection: Prevent EDC Study Name Duplicates
• eCOA-Clinical Operations Connection: Auto-Create System Links
• RIM-Clinical Operations Connection: Updates to Submission Tracking for Clinical Trials
• RTSM-Clinical Operations Connection: Auto-Create System Links
• Safety-Clinical Operations Connection: Match Countries Based on Code
• Safety-Clinical Operations Connection: New Integration Field Rule
• Safety-Clinical Operations Connection: Setting Product in Clinical Operations
• Study Training-Clinical Operations Connection: Auto-Add Differentiated Security Profiles
• Study Training-Clinical Operations Connection: Auto-Create System Links
• Study Training-Clinical Operations Connection: Auto-Sync Clinical User Status in Study Training

All Clinical Operations Applications

Simplified License Display & Enforcement

A common challenge is ensuring you are using the applications contracted for you. Veeva Clinical Operations’ licensing is based on a per-site model, making it crucial to accurately track Study Sites consumed by individual applications. Without a reliable way to monitor this, it’s difficult to understand overall license usage and ensure compliance. Today, you can already see contracted and consumed license amounts for each application by navigating to the Admin > About > License Information page.

This new feature simplifies the visibility of license tracking and enhances business continuity.

Previously, both the TMF Licenses summary and Active TMF Licenses sections were visible on the License Information page, causing confusion. Additionally, counts for inactive Study Sites were visible even though this was not tracked towards licensing. To address this, the TMF Licenses summary section and Inactive Study Sites count have been removed. This leaves a single, clear, and comprehensive section for each application, making it easier to get a complete picture of your usage, as you can see below:

With this change, we’ve also removed the blocking of new Study Site creation when a customer exceeds their TMF license limit. This will provide consistency with our TMF license calculation which does not count sites toward licensing until a document is created and will unblock users from creating core Clinical Operations data.

Clinical Operations Object Redirect URL

This feature supports a seamless connection between Veeva EDC and Veeva Clinical Operations by allowing users to click a new, stable URL in their EDC Vault and be automatically redirected to the corresponding Site record in their Clinical Operations Vault. This enhancement significantly reduces manual navigation and ensures that users can quickly access the correct information.

Additionally, this URL containing the Site’s unique identifier enables a direct link from any external system. When a user clicks this URL, the system reads the object type and object global ID to find and display the correct Site record Detail page.

Grant Study Person Access on Start Date

This feature enhances the existing Revoke Access from Study Persons with End Date job to include logic to grant access. The job will be relabeled to Manage Study Person Access Based on Start and End Dates and in addition to removing access for Study Personnel, when the Start Date is reached on a Study Person record and the new Grant Access on Start Date field is checked the job will also:

• Set the Grant Access to Related Records field to Yes when the related Person record is not an Investigator or Site Staff object type
• Set the Site Connect User field to Yes in Vaults with Site Connect when the related Person record is an Investigator or Site Staff object type

When a Site Staff Change Request is approved, the system automatically checks the Grant Access on Start Date field for related Study Person records with a future Start Date value. This job will be activated in Site Connect Vaults on release night.

Editable External ID for Study Team Roles

External IDs are crucial for integrating data with external systems and ensuring consistency across the customer ecosystem. These IDs often need to be updated due to changes in external system configurations, data migration, or simply to correct errors. Previously, if Study Team Roles were assigned to Study Persons with Grant Access enabled, the External ID could not be modified without revoking individual access. This not only created a manual burden for Admins but also disrupted business continuity for end-users, as their access would be temporarily removed.

This enhancement significantly simplifies the process. You can now directly edit the External ID field on Study Team Roles and Role Dependencies, even when those roles are in use by Study Persons with Grant Access set to Yes. This means you no longer need to revoke access or disrupt ongoing work to make these crucial updates, providing greater flexibility and efficiency in managing your study team configurations.

Workflow Support for Create Document from Word Formatted Output Templates

This feature streamlines the creation and filing of key documents in your eTMF Vault by automating the process within a workflow.

This new functionality allows you to generate documents using Word Formatted Output templates directly from object record data using a Workflow Job Step. The workflow will automatically pause until the document is successfully created and filed in the Vault library as a corresponding eTMF document. This ensures the finalized document is in the eTMF upon the workflow’s completion, which helps to improve compliance.

This feature is designed to replace the legacy Create Trip Report system action, allowing you to generate Monitoring Event Trip Reports using Word Formatted Output templates. It can also be configured for any other object to generate documents such as Confirmation Letters, Follow-up Letters, Payment Letters, and Survey Responses.

Optional Subartifact Value for Generate Formatted Action

In Vault with Subartifacts enabled, users are no longer required to specify a Subartifact value when configuring the Generate Document from Formatted Output Object action.

CTMS

Monitoring Event Review Comment Badges

We have updated Monitoring Events to make it easier to locate and navigate to open comments.

Sections containing unresolved review comments now show a speech bubble icon on the section header and in the Navigation Panel. Clicking the icon automatically opens the relevant section, helping users find open comments faster.

Monitored Metrics: Evaluate Subject Dates & Actual Visit End Date

This feature enhances Monitored Metrics for Studies using date-based metric calculations. Previously, the Seed Monitored Enrollment and Proactively Seed Monitored Enrollment system actions would capture all subject data at the time of execution. If these actions were taken after the Monitoring Event’s end date, this resulted in data being included that was not valid at the time of the event.

Now, these actions respect the Monitoring Event record’s Actual Visit End Date value and only include Subject dates and Subject Visits that occurred before or on the end date when run on Date Based Studies, providing an accurate snapshot of the data from the specific time of the Monitoring Event.

Enrollment Rate Calculation Improvements

We’ve improved the way the system calculates Enrollment Rate (subjects per month) to provide a more accurate and realistic average. The previous calculation used a fixed 30 days per month. The updated calculation is now more precise, using 30.436768 (the average number of days per month).

In addition, the calculation now accounts for the enrollment period by factoring in the Last Subject In Milestone’s Actual Finish Date.

• When the Last Subject In Milestone has an Actual Finish Date, the system calculates the Enrollment Rate using the enrollment period: (Total Enrolled / # days between First Subject In and Last Subject In Milestone Actual Finish Dates) * 30.436768
• When the Last Subject In Milestone does not have an Actual Finish Date, the system calculates the Enrollment Rate based on the time elapsed since the start of enrollment: (Total Enrolled / # days since First Subject In milestone Actual Finish Date) * 30.436768

These updates are also made to the Enrollment Rate calculation for Monitored Metrics.

Seed Metrics via User & Workflow Actions

The ability to effectively plan and track subject recruitment metrics (screened, enrolled, randomized) is crucial for the success of any clinical trial as it directly impacts budget allocation or project timelines. Previously, Vault’s automated generation of these Metrics records was strictly tied to lifecycle state changes.

This new feature introduces a dedicated user action to Seed Metrics Records. This on-demand action empowers users to manually generate Enrollment Metrics records at the Study, Study Country, and Study Site levels whenever they need to. This is the ideal solution for:

• Seeding Metrics records for new Study Countries or Study Sites added after the Study lifecycle state change
• Generating new Metrics records to include Arms or Cohorts that are added while the Study is in an Active state

Enrollment Metrics: Consistency & Error Handling Improvements

This feature introduces enhancements to the Update Metrics, Update Metrics (Metrics Only), and Recalculate Enrollment Metrics jobs to improve consistency and error handling.

The following updates are applicable to all the jobs:

• New job notifications
• Updated job log details
• Handling of duplicate Metrics records
• Respect Metrics Not In Use and Global Subject Metric Enablement status
• Vault now uses Study Milestones as a fallback when Subject Group-specific Milestones are not defined

The following enhancements are job specific:

• Update Metrics
  • The Update Metrics job is now scheduled and runs on a per-study basis
• Update Metrics (Metrics Only)
  • Update Metrics (Metrics Only) job is now scheduled and runs on a per-study basis. The label has also been updated for clarity from Update Metrics (Metrics Only Studies) to Updated Metrics (Metrics Only)
• Recalculate Enrollment Metrics
  • For Metrics Only Study records, adding or removing a Metric type from Metrics Not In Use no longer automatically schedules the Recalculate Enrollment Metrics job
  • When a Subject Group’s Track Enrollment Metrics field is changed from True to False, the Recalculate Enrollment Metrics action will no longer set existing Subject Group Metric values to zero, preserving historical data
  • For Date-Based and Status Snapshot Study records, the Recalculate Enrollment Metrics job now only creates new Metrics based on the Study’s subject data if a Metric record for that level does not already exist. The Seed Metrics user action or workflow system action can be used to create a full set of Metrics records
  • The Recalculate Enrollment Metrics job does not make changes when no Subjects exist for a Status Snapshot Study

Prevent Recalculate Enrollment Metrics for Transferred Metrics

The Recalculate Enrollment Metrics action now prevents users from applying it to Study records where the Metric Calculation is set to Transferred Metrics. External processes, such as Vault Loader or an integration, create the metric values for when a Study record uses Transferred Metrics. Therefore, recalculating these metrics within the system is not applicable. Users who attempt to use this action on a Transferred Metrics Study now receive an error message that indicates the action is only available for Studies where the Metric Calculation is set to Date-Based, Metrics Only, or Status Snapshot.

Refine Auto-Populate Last Subject In, Randomized & Started Treatment Milestone Logic

Building on the logic introduced in 25R2, this update refines Automated Enrollment Milestone behavior for Last Subject In, Last Subject Randomized, and Last Subject Treated milestones. By including a broader range of statuses and dates, we can provide more granular and precise tracking of when these milestones are completed.

The updated criteria for these milestones are:

Milestone Type	Auto-Populated Value
Last Subject In	The latest Enrolled Date of the Subject if all Subjects for the Study Site have either:     - A Subject Status of Screen Failure, Enrolled, Randomized, Started Treatment, End of Treatment, Started Follow Up, Lost to Follow Up, Complete, Withdrawn, or Deleted in CDMS     - A value in the Screen Failed Date, Enrolled Date, Randomized Date, Started Treatment Date, End of Treatment Date, Started Follow Up Date, Lost to Follow Up Date, End of Study Date, or Withdrawn Date
Last Subject Randomized	The latest Randomized Date of the Subject if all Subjects for the Study Site have either:     - A Subject Status of Screen Failure, Randomized, Started Treatment, End of Treatment, Started Follow Up, Lost to Follow Up, Complete, Withdrawn, or Deleted in CDMS     - A value in the Screen Failed Date, Randomized Date, Started Treatment Date, End of Treatment Date, Started Follow Up Date, Lost to Follow Up Date, End of Study Date, or Withdrawn Date
Last Subject Started Treatment	The latest Started Treatment Date of the Subject if all Subjects for the Study Site have either:     - A Subject Status of Screen Failure, Started Treatment, End of Treatment, Started Follow Up, Lost to Follow Up, Complete, Withdrawn, Deleted in CDMS     - A value in the Screen Failed Date, Started Treatment Date, End of Treatment Date, Started Follow Up Date, Lost to Follow Up Date, End of Study Date, or Withdrawn Date

This feature is auto-on for Vaults with Enable Automated Enrollment Milestones enabled.

Study Product Defaulting for Document Generation

This feature enhances the Create Related Document From Template and Generate CTN Document actions to automatically apply Study Products with the Study Role of Lead Agent to the Product Document field.

Japan CTN Submission: Data Change Visibility

This feature improves the logic for generating subsequent Japanese Clinical Trial Notifications (CTN) and automates the tracking of Internal IRB changes. The logic for generating subsequent CTNs has been updated to prevent previously submitted changes from being copied again. A new field, Do Not Copy in subsequent CTN, is now set to Yes when a change log record has been successfully incorporated into a CTN document. This ensures that only new and unsubmitted changes are included in subsequent CTNs, streamlining the process and preventing duplicate submissions. Additionally, the system now automatically generates CTN data change logs when the Internal IRB checkbox is checked or unchecked for a Site. When a user unchecks the box, a DELETE CTN Data Change Log is created, while checking the box creates an APPEND CTN Data Change Log. These change logs are automatically associated with the correct position in the CTN, so that all changes to a site’s IRB status are accurately and automatically reflected.

Japanese CTN Generation: Organization Tracking Details

This feature streamlines the Japanese Clinical Trial Notification (CTN) submission process by automating the inclusion of the Trial Applicant’s organization name in the CTN XML filename and providing new organization roles for vendors.

This enhancement benefits Vault users by ensuring compliance with the Pharmaceuticals and Medical Devices Agency (PMDA) and making the submission process more accurate and efficient. Previously, users had to manually edit the XML filename to meet regulatory requirements. Now, the system automatically generates the filename with the Trial Applicant organization name, removing a time-consuming manual step.

Additionally, a new Study Organization Role, SMO (Site Management Organization), has been created. Organizations with this Role are now included in the SMO section of the CTN submission. Previously, users had to work around limitations in available Organization Types for vendors. The new SMO Role streamlines the submission by making it easier to include a wider range of relevant organizations. Users will see these changes when they prepare a CTN for submission, where the XML filename will be correctly generated and the new Role will be available for Study Organizations.

Clinical Transfer CDX Enhancements

This feature improves CTMS Transfer error message handling when records cannot transfer due to the following:

• The system attempts to transfer a Study Country but the associated Country record is not mapped to a Veeva Standard Country.
• The system attempts to transfer a Study Site but the associated Study Country does not exist in the target Vault.

Now, when the records are blocked from transfer, the error message is more clear and users can understand the steps needed to resolve the issue.

CTMS Transfer: Improved Object Type Field Handling

Transferring clinical trial data between a Contract Research Organization (CRO) and a Sponsor can be problematic when their Vaults have different configurations. Specifically, when using the CTMS Transfer feature, if a standard field is transferred from a source Vault but is not present on the corresponding object type in the target Vault, the entire record transfer fails. This prevents valuable information from reaching the Sponsor and requires time-consuming configuration changes to fix, which can disrupt business operations. The inability to transfer data due to minor configuration differences creates unnecessary friction and delays in the CTMS Transfer process.

The CTMS Transfer now accommodates these configuration differences, ensuring that records successfully transfer even if a standard field from the source Vault is not present on the target Vault’s object type. The new feature will simply transfer the record without populating the value in the missing field. This avoids a complete transfer failure and allows the rest of the valuable information to be received by the Sponsor. A new warning message is included in the Agreement Transfer CSV to notify the Sponsor of the skipped field.

This enhancement streamlines the data transfer process and minimizes the need for disruptive configuration changes, providing a smoother experience for both CROs and Sponsors.

CTMS Transfer: Milestone Enhancements for Complex Trials & Cycle Times

As new CTMS features arrive to support additional Complex Trial use cases and new SSU features arrive to support key Study and Country documents cycle times, CTMS Transfer should continue to support new standard fields and values. With this feature, the following fields are now in scope for CTMS Transfer:

• Study Country Subject Group (study_country_subject_group__v) on the Milestone object
• Study Site Subject Group (study_site_subject_group__v) on the Milestone object

Additionally, the following Milestone Type picklist values are now in scope for transfer and can be leveraged in Outbound Clinical Mappings:

• Primary Outcome Completed (primary_outcome_completed__v)
• EU CTR Country Approval (eu_ctr_country_approval__v)
• Site EC/IRB Application (site_ec_irb_application__v)
• Site EC/IRB Approval (site_ec_irb_approval__v)
• Other Country Application (other_country_application__v)
• Other Country Approval (other_country_approval__v)
• Other Site Application (other_site_application__v)
• Other Site Approval (other_site_approval__v)
• Key Country Docs Complete (key_country_docs_complete__v)

CTMS, Disclosures, eTMF

Standard Fields for Study Phase

This feature adds standard values to the study_phase__v picklist as inactive to allow triggers, prepopulation, and rules functionality for Disclosures. An Admin will need to activate these values, inactivate the existing values, and migrate existing records.

CTMS, eTMF

TMF Transfer: Skip Unretrievable Renditions

TMF Transfers can involve a large volume of documents for studies that have been ongoing for years. Due to this volume and time frame, some problematic documents may be included in the transfer scope. For example, some documents may predate the platform’s current corruption checks and PDF validations. In cases of severe corruption, the viewable rendition of a file can not be downloaded for transfer, causing the entire document transfer to fail. This creates a large amount of extra work, as users have to manually filter out these files and handle them separately, which reduces the benefits of using TMF Transfer.

This new feature solves this problem by automatically transferring only the source file of a document when the viewable rendition is present but cannot be downloaded for transfer. When this happens, a warning is raised to alert you of the action taken.

This enhancement saves users a significant amount of time by eliminating the need to manually identify and process these files, ensuring a smoother and more efficient transfer process.

CTMS, eTMF, Study Startup

Create Site Person EDLs

Today, when a new Study record is associated with Personnel, Organizations, and Products, the system creates Expected Documents when EDL Automation is enabled. This is problematic for Study Site Personnel added during feasibility, as it prematurely inflates TMF completion metrics. This feature gives a solution to automate the timing of Site Person Expected Document upon Site selection using a new system action workflow step for the Site lifecycle.

The new system action workflow step is used to create Expected Documents for existing Study Personnel associated with a Study Site at the point of workflow initiation. The EDL Template Refactor flag must be enabled to leverage this new System Action within a Study Site workflow.

Weekday-Adjusted Offsets

This feature updates Milestone Dependencies to automatically adjust offset planned dates that fall on weekends.

Previously, using a date offset to plan downstream milestones could result in a calculated date on a Saturday or Sunday. Now, the system will automatically shift that date to the following Monday. This update reduces the need for manual date adjustments, saving time and improving data accuracy. This change is applied only when the offset is greater than zero and the calculated date falls on a Saturday or Sunday.

Autocomplete Job Refactor

The Autocomplete Job Refactor update improves the reliability of Milestone Autocomplete functionality by reducing processing errors. Previously, the Autocomplete job processed multiple Milestone records in batches and if one Milestone encountered a failure, the entire batch would fail to process. Now, the job will continue to process each Milestone record within a batch, regardless of whether it encounters an earlier failure.

Additionally, any failure to populate the Actual Finish Date or move the Milestone to the Complete state will not prevent the job from calculating Milestone Completeness. This is achieved by calculating the Milestone Completeness first, and then the system attempts to complete the Milestone in a separate job, five minutes later. This means that users will see an additional five minute delay when waiting for Autocomplete to populate the Actual Finish Date and move the Milestone to the Complete state.

Milestone Document Version Backfill Job

To facilitate the deprecation of the Milestone Document field and the introduction of a new Milestone Panel in an upcoming release, we need to first ensure a robust association exists between documents versions and milestones. The new Milestone Panel will give users a comprehensive view of all milestones related to document versions, but it will rely on the existence of Milestone Document records. Previously, Milestone Document records only existed for the latest version of a document, but moving forward the system will create Milestone Documents for the latest version and every previous steady state version.

This release proactively addresses data integrity with a new automated job that runs upon upgrade. It scans all documents and their steady-state versions, automatically generating any missing Milestone Document records. This ensures all past steady-state and latest document versions have accurate, corresponding Milestone Document records. Additionally, we have updated the milestone creation functionality to prevent any future gaps in your data.

The additional Milestone Document records will present new information in the Milestone Workspace. The matched documents panel will now display a row for the latest version of a document and every previous steady state version. Additionally, the Total Documents and Total Approved metrics in the Milestone Workspace section will count previous steady state versions as well as latest versions, meaning Superseded Documents count towards Total Documents and Total Approved.

CTMS, Payments

Complex Trials: Visit & Procedure Tracking

This feature improves how Veeva Payments handles reimbursements for Studies using Subject Groups, providing more granular tracking and ensuring payment accuracy.

Now, Subject Group details are automatically populated on related Subject Visit and Procedure records if the Subject is assigned to a Subject Group and the Visit or Procedure has a date. Additionally, if the dates on a Subject Visit or Procedure are cleared, the corresponding Subject Group data on that record is cleared as well.

Payments uses these Subject Group values to generate and, if enabled, adjust Payable Items. It does this by matching the Subject Group criteria defined on Fees to the Subject Group on the Visit or Procedure record. This ensures that any later changes to a Subject’s group will not impact past payment activity.

Upon release, the system will automatically update existing Subject Visit and Procedure records to reflect the Subject Group assignment on the Subject.

Disclosures

Ability to Import & Store Adverse Events Results Data from XML

To save users time and reduce errors, this feature allows you to import an Adverse Events Results XML file to populate the Adverse Event section in US Results.

Disclosures: Protocol & US Results Updates

This feature adds new fields added to the Protocol object for pre-populating Disclosure record fields, and new functionality to US Results for efficiency. We have also added the ability to copy Outcome Measures, copy Adverse Events, and Fill from Registration to Arms and Outcome Measures.

Disclosures Validation Improvements: US Results

Users now have an action to validate and show all errors on-screen for US Results while still editing the Disclosure record. Vault will connect to ClinicalTrials.gov PRS Test to validate and display all errors, ensuring current and comprehensive pre-validation for Results submissions.

Migration Tool: Import US Registration XML

This feature grants the ability to bring in all existing Registration and Disclosure records to Vault with matching Studies, for all in progress studies and studies closed in a given timeframe.

Publish to CDN & Post Disclosure Documents for Company Website Support

Utilize the Digital Publishing functionality to publish any configured documents on a Disclosure record to a customer’s S3 bucket for hosting, including the documents and URLs in the Custom Website XML.

eTMF

TMF Export

This new self-service feature provides a simple way to create a complete, transferable package of TMF documents, metadata, and audit trails for a single Study. This feature is designed to simplify the process of sharing study documents, particularly for CROs transferring the TMF to sponsors, and will address current limitations with binder-based exports, such as size limits and the need for manual reassembly.

The export is initiated with a user action on the Study object, where you can select specific document lifecycle states and file types, and choose whether to include unblinded content, source files, and attachments. Administrators can also create and save reusable templates with a new TMF Export Configuration object to streamline this process.

Once started, the export runs as an asynchronous, auditable job that can be canceled by an Admin. It uses the permissions of the user who initiated it, so only accessible documents are included. The final export package is delivered to the File Staging Server in a familiar folder structure based on the TMF Reference Model, and contains all relevant documents, a human-readable CSV of document metadata, a separate audit trail CSV for each document, and a log of any documents that failed to export. Once completed, the zipped export will be available for download by the initiating user from the File Staging Server for up to two weeks.

Create Single SEC Quality Issue When Reclassifying & Using Subartifacts

In 25R1, Self-Evident Corrections were introduced to allow users to fix specific document metadata errors while Vault tracks and resolves related Quality Issues. When subartifacts are used, reclassifying a document also changes its subartifact, which would normally create two Self-Evident Correction Quality Issues (QIs) if the Subartifact is listed in a different SEC Configuration record than the Classification. To prevent redundancy, the update ensures only a single QI is created in these cases to streamline the process and avoid duplicate issue tracking.

TMF Bot Prediction Metrics Enhancement

To give you a more current and granular view of TMF Bot activity, we have enhanced the frequency Prediction Metrics updates.

Previously, Prediction Metrics were updated monthly. Now, the system updates these records daily, providing a more accurate and timely reflection of TMF Bot activity and performance.

Additionally, a new set of Prediction Metric records will now be created with each new release, instead of monthly. This change offers you a clearer view of TMF Bot performance over a release cycle, making it easier to assess changes in accuracy from one release to the next.

eTMF, Study Startup

Remove Need for Power Delete Permission for Deletion with Reason

In 25R2, Delete Document with Reason functionality was introduced to maintain records of documents deleted from the system when the document itself was permanently removed. This enhancement allows an end user who has been granted access to execute the configured Delete Document with Reason user action, to execute the action without having to have Power Delete permissions, which was previously required. Instead, the system will delete the document on behalf of the individual executing the action and the related deletion log will capture the user who initiated the action.

OpenData Clinical

Create New Record Action from Resolved DCR

This feature introduces a new Create Missing Record action on resolved Data Change Request (DCR) records that resulted in a new OpenData Clinical record. After Veeva data curator review and verification, a Data Change Request for a new Investigator or Institution can result in a new record added to the OpenData Clinical database.

This new action enables users to quickly and easily create the newly added Investigator or Institution record directly from the resolved DCR. The new record will be automatically populated with the OpenData ID from the resolved DCR and linked to the DCR after creation.

Removed & Excluded OpenData Clinical Records

This feature introduces the ability to manage Investigator and Institution records that have been removed or excluded from OpenData Clinical due to reasons such as an investigator retiring or a site going out of business.

When a Person or Organization record in your Vault is linked to an OpenData Clinical record that has been removed or excluded, the Vault record’s Excluded from OpenData Clinical field will be set to TRUE and the OpenData Exclusion Reason will be populated. This ensures you can retain and continue to use these records for operational purposes while clearly identifying them as no longer maintained by OpenData Clinical.

Obsolete OpenData Clinical Check for Updates Job

When the OpenData Clinical Check for Updates job runs, it will no longer perform any actions as the existing functionality is now handled in a cross-Vault job. The OpenData Clinical Check for Updates job will be deprecated in a future release.

Payments

Fee Template Selection

This new feature gives Payments users more control over Fee Template selection. Previously, Vault only allowed one approved Fee Schedule Template per Study or Study Country, with automatic selection of that template. With this feature, users can now select from multiple approved Fee Schedule Templates when creating Fees for a Study Site. This enhancement provides greater flexibility in choosing the most appropriate template, allowing for variations tied to different approved amendments or institution types, so that users can more accurately set starting Fees for a Site. This feature can be enabled via Vault Settings.

Payments: Exclude from Threshold

This feature introduces the ability to override existing payment thresholds. You can now designate specific Fees in a Fee Schedule or individual Payable Items to be paid regardless of any outstanding advances or predefined payment thresholds. This ensures that essential payments can be made to sites even when an advance has not yet been fully recouped or when immediate payment is otherwise required. This feature requires configuration to enable.

Restrict Payment Request to Study Organization

This new feature gives customers greater flexibility in managing Payment Requests. You can now prevent the automatic grouping of Payment Requests for a Study Organization within a Study. This allows for the tracking of specific costs tied to different entities or distinct cost structures, such as various purchase orders, so that your organization can maintain separate payment records for these items.

Invalid Fees

With this feature, we have introduced support for invalidating Fees on approved Fee Schedules, enabling users to quickly and easily correct data entry errors without requiring a full revision to the entire schedule.

Now, users can set a Fee as Invalid and the system will automatically take appropriate action. New behavior includes:

• Invalid Fees do not generate new Payable Items.
• Invalid Fees are not copied when the Copy Fee Schedule with Related Fees action is taken.
• For customers with Automated Payment Adjustments enabled, if a Fee is changed to Invalid after a Payable Item has been created, the system will automatically handle the adjustment, either marking the Payable Item as Inactive or creating an adjustment Payable Item. The adjustment reason is recorded as Fee Updated to Invalid.

Validation checks are included to prevent the inactivation of Fees that have active Payable Items associated with them, ensuring data integrity.

Bulk Action to Generate Payment Requests

A new user action is available to allow users to Generate Payment Requests at the Study, Study Country, or Study Site level using the Bulk Action UI. When enabled, users can initiate the Generate Payment Requests action for multiple Studies, Study Countries, or Sites in a single action. Results will be processed individually and corresponding results provided.

Fee Base Amount Populates Amount When Blank

This feature provides consistent behavior to customers using the Fee Base Amount field. If users update the Fee Base Amount field and leave the Amount field blank, the system will populate the Amount field even when the Include Overhead field is set to No or blank. Previously, the system only populated the Amount field when the Include Overhead field was set to Yes.

Payments: Exclude Events with Subject Groups

This feature improves how you can define Fees for Studies using Subject Groups. A new field, Exclude Subjects with Subject Groups, has been added to the Fee and Fee Template objects. When this field is set to Any Subject Groups, the Fee will only apply to Subjects who are not assigned to any Subject Group. This is useful for studies that add subject groups later or for studies with substudies that apply to only a portion of the subjects. This feature can be enabled by activating the corresponding picklist value.

Payments, Site Connect

Payment Requests: Additional Lifecycle States

The following lifecycle states have been added as standard to the Payment Request Lifecycle (payment_request_lifecycle__v) to provide more complete support through the entire process, including several alternate outcomes. The states added are:

• Paid (paid_state__v)
• Cancelled (cancelled_state__v)
• Rejected (rejected_state__v)
• Requested from Site (requested_from_site_state__v)
• Received from Site (received_from_site_state__v)
• Payment Pending (payment_pending_state__v)

Additionally, for customers with Site Connect, the Payment Pending state and Paid state are included as visible options from the Payments tab in Site Connect.

Site Connect

Site Front Door in VeevaID

This feature allows site users to view the list of Site Connect Studies they have access to in each Sponsor/CRO Vault via the VeevaID homepage (id.veeva.com). Previously, site users could access individual systems from the VeevaID homepage, but there was no knowledge of which studies were being run in which Vaults. Selecting a Study will take the site to the system links tab in Site Connect for that Study.

With this streamlined approach, this feature serves as a single gateway for site users to access all Site Connect studies in one place.

Auto-Distribute Milestone Documents

This feature enhances the Automated Document Exchange feature by allowing Sponsor/CROs to block automated document sending and requests until a specific milestone is reached (e.g., HA approval), thereby enabling them to have greater control over the document exchange process.

This new functionality is managed through a new picklist field, Auto-document Exchange, which has two values: Allowed and Blocked. By default, this field is inactive and exists on both the Template Milestone and Milestone objects.

• Documents: When a document is marked for auto-distribution, the system will check all related milestones that the document is a part of ensuring that none are blocked before distributing the document to the site.
• Document Requests: Document requests from Expected Documents will be auto-created only if they do not belong to a blocked Milestone.

Activation of Standard Site-Level Roles

In 25R2, the following Site-facing Study Team Roles and Application Roles were introduced as Inactive. These Study Team Roles will be made Active in all Site Connect Vaults.

• Budgets & Contracts (budgets_contracts__v)
• Data Coordinator (data_coordinator__v)
• Other Non-Investigator (other__v)
• Pharmacist (pharmacist__v)
• Regulatory Coordinator (regulatory_coordinator__v)
• Research Nurse (research_nurse__v)

In addition, the Site-facing Study Team Roles and Application Roles that were available prior to 25R2 will be made Active in all Site Connect Vaults.

• Principal Investigator (principal_investigator__v)
• Subinvestigator (subinvestigator__v)
• Clinical Research Coordinator (clinical_research_coordinator__v)

Revise & Return for Study- or Country-Level Documents

This feature enhances and simplifies Document Exchange for Sponsors/CROs by enabling sending study or country-level documents to Sites for a Revise and Return task.

This feature is particularly helpful for clinical documents, such as Protocol signature pages, that often originate as study-level or even country-level documents and when sites receive these documents, they must download, sign, and re-upload them back into the system to finalize them as site-level documents. An alternative approach currently used is Sponsor/CROs creating site-level copies of these documents and assigning these as Revise and Return tasks to Sites, which is cumbersome, time-consuming and repetitive.

With this feature, when the document is returned from the Site upon completion of the task, the system creates a site-level document in the Vault.

Set Site Connect Reply To Email

This feature enables defining a Study Site-specific reply-to email address available from Document Exchange emails that are requesting documents. An email is automatically started when the site selects “click here” in the Document Exchange email with the appropriate reply-to email, email title, and email body.

Previously, site users who operated via email would need to remember which Sponsor/CRO contact to send documents to for each study they were involved with. This feature makes this process easy for Sponsors/CROs who want to have a defined process for supporting sites who want to work via email.

The reply-to email address is configurable via a new text field called Site Connect Receiving Email on the Study Site object, which enables specifying the recipient email for documents sent back from the sites.

When the Site Connect Receiving Email is configured for a Study Site, this email address will be set as the reply-to email when the user clicks the link to upload and send the requested documents.

Site Staff in Site Connect

This feature empowers sites to manage their own site staff within Site Connect. Historically, Sponsors/CROs were responsible for manually maintaining this information after being notified via email or in-person about site staff changes, which could lead to delays and inaccuracies. Now, sites have visibility into the site staff tracked by the Sponsor/CRO and can make changes to the list of site staff members as appropriate, without manual communication.

Sites can access this new functionality from the Site Staff page located under the Site Profile section in Site Connect. From this page, site users can add new Site Staff, as well as view and manage their Start and End Dates, Roles, and Responsibilities on the Study. When a site user creates or updates site staff details, the system creates a Site Staff Change Request for the Sponsor/CRO to review.

Sponsor/CRO users will see these requests in a dedicated Open Site Staff Change Requests section on the Study Site page. The Sponsor/CRO user can link the new site staff member to an existing Study Person record or create a new one and then approve the change request, which then grants the user access to Site Connect based on their Start Date. If rejected, the site user who initiated the change will receive a notification with the reason.

Automate Site Staff Creation

This optional feature complements the new Site Staff in Site Connect feature by automating the process of creating or linking a Study Person and Person record when a new Site Staff Change Request is approved. This enhancement removes the manual step that requires a Sponsor/CRO to create or link the correct records. This benefits Sponsor/CROs and Vault Admins by streamlining the approval process and reducing the risk of human error.

An application setting called Automate Site Staff Creation enables the system to create or link Study Person and Person records when a Sponsor or CRO approves a Site Staff Change Request. The system uses a combination of First Name, Last Name, and Email to find the correct Person, and a combination of Person, Start Date, End Date, and Study Team Role to find the correct Study Person. If no matching record is found, the system will automatically create a Person and/or Study Person record.

Remember Site Staff Roles & Responsibilities

With this feature, when Site Admins add a Site Staff member to Site Connect, the system remembers the Role and Responsibilities that were selected for the site user. The next time that the Site Staff member is added to Site Connect for a Study, the remembered Role and Responsibilities will be defaulted as a starting point that can be modified if needed.

This can simplify Site Staff management and provides a more streamlined user experience for site users adding other Site Staff.

Copy Responsibilities When Adding Site Staff

When a site user in Site Connect is selecting Responsibilities for a Site Staff member, they can select another Site Staff member in the same Study to copy Responsibilities from. This can significantly streamline the selection of Responsibilities for staff when adding multiple Site Staff members who need to perform similar tasks.

Site Staff Change Request Configuration Migration

To reduce the burden of enabling the auto-on Site Staff in Site Connect feature, the configuration for the Site Staff Change Request object has been automated. This ensures that the feature can be utilized by all customers on release night by automatically configuring page layouts and security in your Vault. This benefits Vault Admins by removing the need for manual setup and ensuring a smooth transition to the new functionality.

Previously, these configuration changes would have required manual updates to various settings across the Vault. The new automated migration takes care of key areas, including Permission Sets for the Site Staff Change Request object and its object actions, Object Roles for the Site Staff Change Request Lifecycle as well as Matching & Custom Sharing Rules for the Site Staff Change Request object. Additionally, an open Site Staff Change Request section is automatically added to the Study Site page layout.

Site Home User Interface & Navigation Improvements

This feature adds several user interface enhancements to the Site Home Page.

• The Study Site selector has been enhanced for non-site users to support type-ahead search for more accurate results. The default Study - Study Site listing is also updated to show recently visited Studies first, followed by the remaining Studies, sorted to display in alphabetical order.
• An update has been made to the banner text on the end-of-study media page to reflect that SiteVault’s eISF is now free for up to 20 active Studies in a year.
• The verbiage in the change approval dialog for Site Addresses has been updated to reference both Sponsor and CRO.
• Several updates were made to the Site Home UI sections/tabs to facilitate logical grouping and easy navigation for users.
  • Study Admin section is now re-labeled as Site Settings and is now displayed at the bottom of the page sidebar.
  • Site Profile section now houses Site Staff and Site Addresses tabs.
  • Study Contacts section displays Sponsor/CRO Contacts information.
• Several key updates have been made to the Document Exchange grids, enhancing usability and layout to make it easier for users to navigate and focus on key information.
  • Auto-Column Wrapping: All site-based grids, including Safety, End of Study Media, and Document Exchange, will now wrap columns by default for improved readability.
  • Column Reordering: In the Document Action grid, the Sponsor/CRO Comments column will be moved to the first position after the Name column for easier access to critical information.
  • Default Column Width Adjustments: Default widths of the following columns, Name, Description, and Sponsor/CRO Comments, has been reduced in both the Document Action and Documents (All/Sent/Received) grids.

Improved Safety Acknowledgements

Safety Acknowledgement has been simplified to handle site edge cases.

• New Safety Recipients at Sites can now complete acknowledgments for previously shared Safety Distributions, even without an existing Distribution Task Recipient (DTR) on the related Safety Distribution Tasks (DTs). Previously, this was not possible as a DTR must have existed for the recipient to facilitate acknowledgement completion on the related DT.
• Site users who were part of the original distribution but no longer have an active Site Home Access record will not be able to mark Safety Distribution Task(s) as Complete/ Acknowledged.

File to SiteVault Duplicate Document Detection

With this feature, the system now checks for existing document versions in SiteVault when a user performs the File to SiteVault action from Site Connect, thereby avoiding duplicates from being created.

When a user selects the File to SiteVault action from an individual document and a duplicate version is detected, the system will present a confirmation dialog, providing the user with information about the existing document in SiteVault. From this dialog, the user can choose to cancel the filing to avoid creating a duplicate or proceed with filing the document to SiteVault. In instances where documents are filed to SiteVault in bulk, duplicate versions will not be filed if detected.

As a result, this enhancement ensures data integrity, saves site users time and effort by avoiding unnecessary data duplication and cleanup, and provides users with control over how to handle potential duplicates.

Payment Information Enhancements

This release includes several Payment-related enhancements that aims to improve the feature’s usability for site users.

• Site users can now view payment details, including Paid-to-date and Pending amounts, in their local currency on the Payment Information page. In cases where payment requests involve different local currencies, the system will display amounts in Vault currency.
• To ensure data protection, placeholder help text has been added to text fields on the Payments Information page, reminding users not to enter any patient identifying information.
• Site users can download payment letters in PDF format only from the Payments Information section.
• Two new standard lifecycle states have been introduced for Payment Requests: Paid (indicating payment has been processed) and Payment Pending (indicating payment has been approved and is being processed). These states enable site users to view which requests are approved to be paid, pending payment, or have been paid.

Site Connect Hardening

A couple of enhancements to existing functionality are included in this release to better support Site Connect.

• Optimized download speeds for bulk document downloads from document viewer, thereby reducing wait times and improving overall efficiency.
• Last Download Date is now updated only when documents are downloaded by Site Users from the Site Connect UI.

Site Connect, Study Startup

Additional USN Sign Up Enhancements

This feature focuses on enhancing the site USN search and sign up experience. When sites access the Sign Up page from a Site Survey, their First Name, Last Name, and Email will be pre-filled using the Person record from the survey invitation. If accessed from the Study Site Addresses tab, these fields will be pre-filled using the current user’s information. Any changes on the USN Search or Sign Up page will persist when navigating to the FAQ and back.

This feature also includes updates to the sign up instructions and FAQ pages. The set of FAQs available through Surveys will differ from the FAQs available through the Study Site Addresses tab, ensuring that only relevant FAQs are available to sites. These enhancements are auto-on for all Vaults leveraging USN Sign Ups.

Study Startup

New Milestone Types for Autocomplete Approval

This feature provides new milestone types that can leverage the Autocomplete Approval Milestone functionality, which enables autocompletion for approval Milestones when the corresponding submission Milestone receives an Actual Finish Date and a Submission Decision of Approved or Approved with Conditions. In addition to Health Authority Application, Health Authority Approval, EC/IRB Application and EC/IRB Approval, the following milestone types will also be supported:

• Site EC/IRB Application (site_ec_irb_application__v)
• Site EC/IRB Approval (site_ec_irb_approval__v)
• Other Site Application (other_site_application__v)
• Other Site Approval (other_site_approval__v)
• Other Country Application (other_country_application__v)
• Other Country Approval (other_country_approval__v)

Key Study & Country Documents Cycle Times

To support new cycle times relating to regulatory packages sent, new Milestone Types, Global Milestone Types, and Global Milestone Offsets will be introduced.

Milestone Type:

• Key Country Docs Complete

Global Milestone Types:

• Key Study Documents Complete
• Key Country Documents Complete

Global Milestones Offsets:

• Key Study Documents Complete to First Study Site Initiated (Finish to Finish)
• Key Study Documents Complete to Study First Subject Enrolled (FSI) (Finish to Finish)
• Key Country Documents Complete to First Country Site Initiated (Finish to Finish)
• Key Country Documents Complete First Subject Enrolled (FSI) (Finish to Finish)
• Key Country Documents Complete to Initial HA Approval Received (Finish to Finish)

The new Milestone Type will be inactive in all Vaults. The new Global Milestone Types and Global Milestone Offsets are delivered as active components, but Global Milestone Mappings must be configured in order for the new Cycle Times to generate.

“CA” will also be replaced with “HA” in the following Global Milestone Types, their associated descriptions and any Global Milestone Offsets using these Global Milestone Types:

• Initial CA Approval Received is now Initial HA Approval Received
• First CA Approval in Study Received is now First HA Approval in Study Received

Update Standard Questions

This release brings minor updates to existing Veeva Standard Questions including grammar corrections, modified answer types and allowed number of selectable answers. These changes will only be applied to existing Library Questions.

The following Veeva Standard Library Questions (API name) have been updated with this release:

Update to Question Text:

• site_caps_13__v: Does your site have a centrifuge that is available for use?
• site_caps_14__v: Does your site have a refrigerated centrifuge that is available for use?
• site_caps_15__v: Does your site have a refrigerator (2 to 8 degrees) that is available for use?

Update to Answer Type and Max Selectable Answers:

• regulatory_01__v: Radio, max selectable answer set to 1

A new Veeva Standard Question will also be introduced to assess the availability of a licensed pharmacist at a site.

Bulk Actions for Surveys

To optimize efficiencies in Study Startup, new bulk actions have been introduced for surveys. This includes a new object action to Send Checklist Based on Contacts Bulk on the Study Site and Outreach Target objects. Additionally, the Site Survey Invitation and Outreach Survey Invitation objects now have Generate New Link Bulk and Inactivate Link Bulk object actions available. These new actions must be configured as user actions on the applicable objects’ lifecycles to be initiated.

Download Referenced Document in Survey

To support wet-ink signing of CDAs, this enhancement allows survey respondents to directly download Reference Documents within Site Surveys and Outreach Surveys to their device. The download capability will only be available on documents within surveys that are sent after the 25R3 release.

Study Training

In addition to the features described below, the Study Training application also rececived enhancements from the following features described in the Quality: Training section:

• Self Enrollment & Direct Assignment: No Due Date Option
• Display Latest Steady State Documents on Learner Task Page
• Training Homepages: Export Functionality
• My Learning Tab: Announcements
• Veeva Training Enhancements
• TRIA Execution Date Migration

Add Curriculum Group to Training Matrix Builder

With this feature, Training Admins can now manually create a new section on the Training Matrix’s Training Requirement column, resulting in Training Requirements being added to a separate Curriculum. This enables customers to make clear delineations between different chunks of content, such as managing permissions-driven or non-study-specific training.

Admins will be able to create these new sections, which can be both country-specific and non-country specific. Manually-created sections do not automatically inherit documents transferred via the Study Training-Clinical Operations Connection, unless they are country-specific. Users with appropriate permissions can edit these sections as long as the matrix is in the correct state.

Study Training Matrix Review

This feature enables Study Training Admins to send Training Matrix drafts for review to relevant stakeholders and track changes over time, streamlining collaboration and version control. Currently, the process for revising a matrix can require out-of-Vault processes for change collaborations, making it complicated for involved stakeholders.

The review process can be facilitated by a new standard Training Matrix Update Review workflow, which can be leveraged in the relevant matrix lifecycle state, such as draft.

Vault also displays differences between proposed changes and the current matrix through a toggle to highlight proposed changes in the draft matrix interface.

Multi-Study Document Training Requirement Equivalencies

This feature ensures that when multiple Training Requirements are created from the same connected source document, such as a Clinical Operations document with multiple Study values transferred via the Study Training-Clinical Operations Connection, Vault considers these requirements as equivalent (as substitutes) to one another.

When a Learner has completed a Training Assignment for one of the studies, Vault automatically considers the equivalent Training Requirements for other studies created from the same source document as additionally complete. It achieves this by linking the two records with a Substitute rule and Substitute Training Requirement. This streamlines the training process by minimizing repetitiveness for Study Training users.

Training Assignment Resolved Lifecycle State

This feature introduces a new Resolved object lifecycle state for Training Assignments, to act as a terminal state for assignments and address specific scenarios that existing lifecycle states don’t adequately cover. These scenarios include:

• Learners dropping out of a study with incomplete Training Assignments that shouldn’t be canceled or marked as completed.
• Mistakenly assigned training that needs to be acknowledged as invalid without canceling it.

This new lifecycle state enables Sponsor/CROs to manually transition these assignments to the terminal Resolved state, providing a more accurate representation of their status and allowing for better tracking and management. The user can optionally record a Resolution Reason too.The records in this new state are ignored by the system for all future processing.

eCOA

Studio

Conditional and Populated Events

Study Builders can now configure scheduled events to be populated by survey data or made conditionally available based on a previous event or a criteria check. This new feature streamlines workflows and reduces the administrative burden on Site Staff by automating more of the event sequence. Key capabilities include:

• Rule-Populated Event Datetime: An event’s datetime can now be populated automatically using a date or datetime answer from a completed survey. This functionality helps remove the potential for data transcription errors. The Study Builder can specify whether an event is populated by a site, a rule, or an API call. A new Populate Event rule template is available to support this functionality.
• Conditional Events: Study Builders can configure events to become available only after a previous event has been entered or a specific criteria check has passed. This helps prevent Site Staff from working on events out of order and reduces distractions. The existing criteria check rule has a new action, Make Event Available, that allows the Study Builder to define which conditional events become available to sites.

Learn more about creating a populate event rule.

Diary Survey

Study Builders can configure a new Diary survey subtype for ePRO surveys that are available as-needed. This allows Study Builders to define additional labels and a description for the diary that will be displayed on a dedicated page in MyVeeva for Patients. Diaries can also be configured to enable respondents to view submitted responses or start multiple in-progress surveys.

Learn more about diary survey parameters and configuring as-needed diary schedules.

Recurring Notifications

This feature allows Study Builders to configure recurring notifications for the Survey Available and Survey Due reminder notification templates, which saves time by eliminating the need to create multiple, individual notifications. Study Builders can also specify a specific delivery time to ensure notifications are sent at an appropriate hour for MyVeeva Users.

Learn more about the recurrence rule notification parameter.

Rule-Scheduled Triggers

This feature allows Study Builders to create rules that start a survey schedule after a MyVeeva User completes another survey. This feature allows the Study Builder to trigger surveys based on MyVeeva User actions rather than a fixed event date, making your study more dynamic.

Using this new Schedule Trigger rule, the start date and time for the new survey can be based on several options:

• The completion time of the triggering survey
• The triggering survey’s event date
• A specific date or time the MyVeeva User entered in the triggering survey

By automating more of this process, the feature helps reduce manual work and potential human error for Site Staff. It also makes surveys available more quickly to respondents when applicable.

Learn more about creating a schedule trigger rule and how to reference rules in the schedule.

Rule-Triggered Data Exports

This feature allows Sponsor/CRO Staff to automatically trigger an FTP export job from a Criteria Check rule. This feature helps sites quickly share data with other systems, which is particularly useful for time-sensitive workflows like Participant randomization.

This new action is available in the Conditional Actions section of the Criteria Check rule template. When configuring the rule, Study Builders can select Trigger FTP Export Job as a conditional action. The rule-triggered export job is a new type that is limited to a single triggered rule export and cannot be combined with other data types.

Learn more about creating criteria checks and creating an FTP connection.

New Survey Question Type: Survey-to-Survey Linking

Study Builders can now configure a new link question type in a survey that requires respondents to select a previously completed survey. This allows Study Builders to collect related sets of data, such as different diary entries.

When MyVeeva Users or Site Staff answer this new question type, they will select from a list of their previously submitted surveys.

Learn more about configuring a linked survey question type.

New Survey Image Type: Joint Count Interactive Image

This feature enables study builders to add interactive joint count images to surveys. MyVeeva users or site staff can select specific joints on a body diagram to indicate tenderness or swelling. This new component allows sponsors to configure surveys for studies that require joint counts, a common assessment type for conditions like rheumatoid arthritis.

Learn more about configuring interactive images.

New Survey Image Type: Free Draw Image

This feature enables Study Builders to add interactive free draw images to surveys. MyVeeva users or site staff can draw on a blank canvas in response to a question. Users can create, erase, undo, and clear their drawings before saving them as part of their survey submission.

Learn more about configuring interactive images.

Translation History Report

This feature adds a report in eCOA Studio that helps Study Builders more easily reconcile translation versions. Study Builders can access a consolidated, downloadable report that displays the translation changes between collection versions based on the files uploaded for each translation. This can be shared with translation vendors to confirm that no changes affected translated content and that their original Certificate of Translation is accurate for the published version.

Learn more about viewing the Translation History report.

Update Between Schedules to Be Inclusive

This feature allows Between schedules to be configured so that when the event datetime falls within the availability window the survey is made available to the user with a partial window.

Learn more about configuring Between schedules.

CDB Connection - Study Matching

This feature ensures that the system can automatically match studies between Veeva eCOA and Clinical Database (CDB) when both studies have a Clinical Operations connection, even if the study names do not match. This allows Study Builders to easily set up connections and streamlines the flow of data.

General Usability and UI/UX Enhancements

This feature includes usability and UI updates:

• Various text elements in the system and in email notifications have been updated for clarity.
• A character limit of 10,000 is enforced for survey block headings.

25R3 Feature Event Audits

Relevant user actions from 25R3 features are now added as audit events on the MyVeeva audit trail.

eCOA API

API Participant Groups and Event Groups

Sponsor/CRO Staff can now configure Event Datetime and Participant Group data to be automatically populated by an external API instead of by a site user in eCOA or the connected system. Once configured, the system prevents Site Staff from editing or adding values for these fields in Veeva eCOA, reducing duplicate data entry and ensuring data accuracy across clinical systems. This feature also enables Sponsor/CRO Staff to set up an external integration with its own credentials and mapping configuration directly to a UAT study.

Learn more about the participant and event group API updates.

Vault

End-of-Study Media Distribution and Reporting

Sponsor/CRO Staff can now distribute end-of-study media (EOSM) packages to sites in a traceable way for acceptance and data retention. Once EOSM has been generated, Sponsor/CRO Staff can send email notifications to specific Site Staff users to prompt them to review, download, and accept EOSM. The system tracks when the media is sent, downloaded, and accepted for each site.

This feature also improves the efficiency of EOSM generation. If Sponsor/CRO Staff generate EOSM multiple times for a study, files will only be regenerated for sites that have been unlocked since the last time EOSM was generated.

Learn more about sending end-of-study media and site closeout status tracking.

See related feature: Clinical Operations-eCOA Connection: End of Study Media

VeevaID Single Sign-On Support for Veeva eCOA

Sponsor/CRO Staff can now enter a Federated ID when creating a new Site Person record. The Federated ID associates a Site User’s Veeva ID with a third-party Single Sign-On (SSO) profile, allowing them to log in with their SSO credentials. This improves how sponsors and CROs manage Site Staff by supporting additional SSO providers with VeevaID.

Represent Study and Site Status as eCOA Vault Lifecycle States

This feature represents the status of studies and sites as Vault object lifecycle states. This change has no functional impacts and only improves the user experience when editing or interacting with records in Vault, as actions that are not allowed are prevented entirely instead of showing error messages.

General Usability and UI/UX Enhancements

This feature updates the Application Family of eCOA Vaults to eCOA instead of ePRO. This text is displayed when a Sponsor/CRO Staff user views the My Vaults page.

Library Manager

Library Manager Enhancements

This feature includes the following enhancements to help Library Managers find and manage surveys more efficiently:

• Added Filters: The Library includes new Status and Type filters to help you more quickly find the surveys you want, and it remembers your filter selections during each user session, only resetting selections after you log out of the site.
• Updated Survey Status: The New survey status has been renamed to **Draft **to better align with the survey creation workflow.
• Last Published Date: The Created Date column in the survey list has been renamed to Last Published to show the most relevant date for a survey’s current version.
• Download Survey Library Snapshot: You can now download a .CSV file of your entire survey library from the More Actions menu in the Library.

Learn more about searching Library Manager and downloading a Library Snapshot.

eCOA (Sites)

Enhanced Event Datetime Behavior

When a Site Staff member updates an event datetime, the system will now better manage associated surveys to reflect true study compliance. Missed, Available, and Scheduled surveys are now canceled and new instances are created when needed. Completed surveys remain unchanged. This ensures that the Compliance report more accurately reflects what is happening in your study by removing Canceled surveys from the report.

The system also displays information about what will happen to associated surveys when an event datetime is changed, giving Site Staff more control and visibility over their actions.

When all surveys for an event are marked as Missed, a banner is displayed to let the Site User know if they have the ability to update the event’s datetime, which may help users quickly correct events that have an incorrect date added.

Learn more about managing events.

Event Lists Sort by Date and Time

Events lists are now sorted by date and time to show the most relevant actions first. The eCOA Activated event is listed at the top, followed by past events and today’s events (with an icon next to it to help you see where the current date is in the list). Future events and events with no set date are then shown in the order the sponsor/CRO configured.

Learn more about managing events.

Mark Events as Did Not Occur

Site Staff can mark scheduled events as Did Not Occur directly from the event list. This action is available only for events that have no surveys in a final state, and a reason is required for the audit trail. When an event is marked as Did Not Occur, it is treated like a Completed event, which can make the next conditional event available.

Learn more about managing events.

End-of-Study Media Distribution and Reporting

Site Staff can access, download, and accept EOSM sent by the Sponsor/CRO by providing an electronic signature using Veeva eCOA.

Reactivate Participant Impact on Events/Schedules

This feature improves system behavior when Site Staff reactivate a Participant. The system now restores the Participant to the Active status without updating the eCOA Activated event, which may restart schedules. The eCOA Activated date and time represent the initial activation of the Participant in Veeva eCOA.

Site Notification Emails Language Changes

This feature updates email notifications to only be sent in the following supported site languages, based on the country of the user’s study site: Italian (Italy), Japanese (Japan), Chinese (Simplified, China), English (all other countries).

Connected eCOA-eConsent Audit Update

This feature ensures that the correct audit action is attributed in the audit reports when Site Staff create a Participant in a study that is connected to an eConsent study. Previously, the system recorded the action as an import from SiteVault.

Improve VeevaID Navigation for Site Staff

Site Staff can now more easily navigate to VeevaID from anywhere in Veeva eCOA to manage account settings or switch between systems.

General Usability and UI/UX Enhancements

This feature enhances the application to work better for touch screen devices.

MyVeeva for Patients

25R3 Translations and New Languages

MyVeeva Users can now view application text, emails, notifications, and the terms of use and privacy policy in Slovak (Slovakia), Vietnamese (Vietnam), and Bosnian (Bosnia and Herzegovina).

Commercial

In addition to the below release notes, the PromoMats Veeva Connect community offers general release communications, release highlights, and key feature demos.

The following features listed in the Veeva Connections section also affect the Commercial application family:

• PromoMats-CRM Connection: Metadata Sync Integration
• PromoMats-CRM Connection: Product Data Transfer

PromoMats

Claims: Commenting for Review & Approval

To streamline the review and approval process for Claims, we have added commenting functionality to Text Asset records. This new feature allows users to comment on specific fields or sections directly from the Claims detail page. Learn more about commenting on Text Assets.

Claims: Auto-Link PreLaunch Claims

With this release, you can now link new Claim records, prior to their approval, to document content via Auto-Linking. This enhancement provides support for draft messaging in Auto-Linking, which previously only linked approved Claim records, enabling the review of new Claims and new materials in parallel.

With this feature, reviewers can assess new Claims in context and confirm the substantiation is appropriate for both the Claims and the document. When the document is approved, the Claims are auto-approved with it.

Enable Move on Brought-Forward Auto Links

To make it easier to improve brought-forward Auto Links, Vault enables users with Annotate permission to move them, in order to change or restore placement. Moving a brought forward Auto Link converts it to a manual Claim Link.

This is accomplished using the Move option in the Auto Link annotation’s Info Card action menu.

Brand Team Security Management

This feature introduces the concept of brand teams to PromoMats, enabling automation in managing user security via the new objects Team, Team Assignment, and Team Member. For example, with this feature, adding a Team Member to a Team automatically provides that user with the security template associated with their Team Assignment. Learn more about managing brand team security.

Portal: Shareable Portal Links

It is now possible for users to share direct links to a Portal or individual Portal Widgets, including static, dynamic, and system-generated widgets. Links always direct users to the current content of the widget, and respect Vault security, ensuring only authorized users can access the link and subsequent content.

Modular Content: User Mentions for Commenting

With this release, to improve the review and approval process for Content Modules, users now have the ability to mention other users (by using the @ symbol and entering the user’s name) in the same Vault when commenting on Content Modules, Content Module Assets, and Content Module Combinations.

Modular Content: Document Info Panel Enhancements

With this release, we have made various usability improvements to the Modular Content section of the Doc Info Panel. These enhancements include consistent naming for Content Module Assets, the addition of an indicator for Must Use assets, and accessibility improvements to the display of asset names.

eCTD: Flexible Brand Ordering in Bulk Generate

The Generate eCTD Compliance Packages bulk action no longer requires Product values to appear in the same order to correctly group materials for eCTD submissions. Previously, in Vaults where the Sort Multi-select Field Values in Alphabetical Order setting was not enabled, the system would not group documents together when the order of Product values was different.

Show Lifecycle State on Keyword Link Annotations

When viewing Text Asset link annotations, users can now more prominently see the Lifecycle State of the Text Asset on the annotation. Previously, the Lifecycle State was only visible when hovering over the link source. This enhancement keeps this key information readily visible for users.

Veeva AI for PromoMats

Veeva AI: Quick Agent

The Veeva AI Quick Check Agent helps to ensure the quality of a material before it is sent for MLR (Medical, Legal, Regulatory) review. It performs pre-defined quality checks to detect issues related to editorial, brand guidelines, market guidelines, and channel rules. In addition, users can interact with the Veeva AI Chat, where the PromoMats Assistant intelligently responds to the user’s questions and requests regarding the document’s content. Built using the new Veeva AI architecture, the Quick Check Agent and PromoMats Assistant assist reviewers by providing rapid content insights, consistency checks, and contextual suggestions to streamline decision-making and reduce manual review cycles.

Learn more about the Veeva AI Quick Check Agent.

Veeva AI: Quick Check Agent Entry Criteria

Admins can configure a new document lifecycle state entry criteria to ensure documents have run the Quick Check Agent before continuing.

Veeva AI: Show Quick Check in the User's Language

The Quick Check Agent now provides its responses to the user in the language and locale defined in their user profile, therefore improving the experience of interaction for users based on their user-defined language.

Medical

In addition to the below release notes, the MedComms and MedInquiry Veeva Connect communities offer general release communications, release highlights, and key feature demos.

The following features listed in the Veeva Connections section also affect the Medical application family:

• Medical-CRM Connection: Metadata Sync Integration
• Medical-Quality Connection: Transfer of Product Quality Complaints from Medical to Quality
• Medical-Safety Connection: Performance Enhancements

All Medical

Medical Content Taxonomy for Life Sciences

This feature introduces a standard set of document types and subtypes for Medical content. This enhancement improves interoperability of Vault-to-Vault Connections, reduces the burden on Vault administrators, and simplifies the user experience.

The new document types are provisioned as inactive and require configuration to enable.

Medical Data Model Standardization

This feature introduces new standard document fields, document field layouts, picklists, and object fields in Medical.

MedComms

Communications Platform UI

This feature introduces a Scientific Communication Platform app page where users can educate themselves on pharmaceutical product or medical technology characteristics like safety profiles, efficacy, clinical landscape, and more.

Scientific Statements: Auto-Link Reviewed Statements

With this release, you can now link new Scientific Statement records, prior to their approval, to medical content via Auto-Linking. This enhancement provides support for draft messaging in Auto-Linking, which previously only linked approved Scientific Statement records, enabling the review of new Scientific Statements and new materials in parallel.

With this feature, reviewers can assess new Scientific Statements in context and confirm the substantiation is appropriate for both the Statements and the document. When the document is approved, the Statements are auto-approved with it.

Medical Portal: Shareable Portal Links

It is now possible for users to share direct links to a Portal or individual Portal Widgets, including static, dynamic, and system-generated widgets. Links always direct users to the current contents of the widget, and respect Vault security, ensuring only authorized users can access the link and subsequent content.

MedInquiry

Ad-Hoc Documents in Response Packages

With this release, you can now add ad hoc uploaded documents and/or email attachments directly to the Response Package. Previously, you could only add approved documents to the Response Package in MedInquiry, and could not add new documents on the fly.

This feature supports cases where Medical Information specialists want to share documents, such as screenshots, not yet uploaded to MedInquiry, or include documents attached to the original Inquiry, such as for sharing with Safety or Quality teams.

Generate & Attach Case Report to Case Response or Event

This feature streamlines the generation and attachment of the Case Report to the Case Response or Event. Admins can configure a new user or entry action on a Case Response or Event object lifecycle state to attach the Case Report (created from the associated Word Formatted Output template) directly to the record.

Pull HCO & Contact Info from OpenData

The scope of information imported from OpenData can now be configured to include HCO data.

With the MedInquiry data model expanding over the past few releases, the OpenData Connection now meets the need for importing HCO data.

Send Emails to the Email Found in the Case Response

This feature enables the user to determine which of the related Case Contact email addresses the response package should be sent to.

In 25R1, the Case Contact data model was expanded to allow users to add multiple records of the same type of contact information. For example, if a Case Contact has more than one email address, users may add these email addresses as Email records related to the Case Contact. For cases where Case Contacts have multiple email addresses associated with them, this functionality can be configured to give users the option of selecting the appropriate email address at the time that they are drafting an email Case Response.

Only Show Steady State Documents in the Enhanced Fulfillment Document Picker

With this release, the Enhanced Fulfillment Document Picker now includes a Steady State Only filter by default. Admins can remove this criteria.

Steady State Only joins the Product, Country, and Language filters, which show only if those fields are populated.

Quality

In addition to the below release notes, the QMS, QualityDocs, Training, LIMS, and Validation Management Veeva Connect communities offer general release communications, release highlights, and key feature demos.

The following features listed in the Veeva Connections section also affect the Quality application family:

• Medical-Quality Connection: Transfer of Product Quality Complaints from Medical to Quality
• Quality-RIM Connection: Requires Correction State for Change Item
• Quality-Safety Connection: Follow-Up & Single Intake Creation Logic
• Quality-Safety Connection: Provision Standard Product Family & Variant Field Rules
• Study Training-Clinical Operations Connection: Auto-Add Differentiated Security Profiles
• Study Training-Clinical Operations Connection: Auto-Sync Clinical User Status in Study Training

Batch Release

Bill of Materials Check

Vault can now check a batch’s as-built genealogy against its as-designed bill of materials (BOM) to ensure that they match. This process ensures that a product was manufactured to specification, such as ensuring that the correct and latest artwork, labels, packaging, and instructions are included.

Close Disposition Items

Users can make decisions, optionally add justifications, and close individual Disposition Check Items on the Batch Disposition Execution page. Admins can enable this feature by setting the Check Requirement Item Behavior picklist to Automatic & Manual.

Due Date Handling

Admins can configure whether due dates are shown in a date or a date and time format on the Batch Release Execution page. Due dates can be configured under Admin > Settings > Application Settings. This setting comes with a new Disposition Due Date field; the default setting is the date format. Batch Disposition Checks will show the field type selected. Which Disposition Due Date field is shown is configured on the Batch Disposition page layout. Customers may want to swap the current Disposition Due Datetime field with the new Disposition Due Date field.

Genealogy Check Using Bill of Materials

The Genealogy Batch Disposition Check can use the standard bill of materials (BOM) for Related Material records to locate Quality Events in a batch’s genealogy that are tied to materials, like Change Controls, without requiring the full batch genealogy. This feature introduces a new object, Material Genealogy, for this process.

Show My Open Checks

You can filter the grid on the Batch Release Execution page to display only the open Batch Disposition Checks owned by the current user.

LIMS

Design Data Management: Spec Data Builder

This feature simplifies the process of creating and managing design data records in LIMS, making the process faster, visual, and less error-prone.

With this feature, Design Data Admins can easily create or update Spec Data from a single interface.

Design Data Management: Test Definition Builder

This feature simplifies the process of creating and managing design data records in LIMS, making the process faster, visual, and less error-prone.

With this feature, Design Data Admins can easily create or update Test Definitions from a single interface. Design Data Admins can also view a visual preview of the output, helping catch mistakes early and reducing back-and-forth corrections later.

Test Definition Compare

This feature provides a user interface for Design Data Admins and reviewers to easily see what changes were made across the history of a Test Definition, expediting the build and review processes.

Previously, users needed to open and navigate across multiple tabs and/or windows to get a complete perspective on changes. The Test Definition Compare displays the complete hierarchy of a Test Definition in a side-by-side view with a previous version. It clearly indicates whether an addition, a removal, or a modification has been made and provides filters to focus on changes.

Stability Summary Report: Word Formatted Output

This feature introduces the ability to generate a Stability Study Report in Word or PDF format directly from a Lab Study or Lab Study Timepoint. The report consolidates test results across all Timepoints, Storage Conditions, and Orientations. Users can also customize the content to include related information from Lab Study and Lab Study Timepoint, leveraging Vault’s Word Formatted Output capabilities.

Design Data Management: Design Data Portability Performance Improvements

With this release, we have improved performance when importing large amounts of design data records.

Design Data Management: Design Data Portability Support Create New Version

This feature enhances the Design Data Loader to support automatic up-versioning of design data records. When importing to another Vault, the system will automatically detect whether a previously approved version exists and will create a new version if applicable. A new version will not be created if a previous version is found in a non-approved state.

Design Data Management: Design Data Portability Support Non-Vault Owner

With this release, we have expanded the Design Data Loader permission model to allow non-Vault owners to import and export design data records. Non-Vault owners that wish to use this feature should ensure that they have the permissions necessary to conduct the transfer. If the user lacks permissions to read object data, it will automatically be excluded from any exports. Likewise, if a user lacks permissions to create object data, it will cause an error during import.

Add Samples to Empty Test Set

With this release, users can create an empty Test Set and add Tests to it from the Test Set record. Previously, it was necessary to begin a Test in order to create a Test Set to which it is added.

Aliquot Actions: Prevent Misconfiguration

The following rules are now enforced when creating an Aliquot Action:

• The Aliquot Action’s Aliquot Sample Definition (target_sample_definition__v) cannot be greater than zero.
• Select Sample Actions that reference an Aliquot Action cannot have a Pull Count greater than one.

Auto-Population of Key Fields for All Stability Lab Samples

With this update, the key fields Study, Study Timepoint, Time Stored, and Time Stored Units are now automatically populated for all Stability Lab Samples and remain in sync with their associated Spec Execution. Previously, these fields were only set when Quantity Tracking was enabled. Manual entry of these fields on Lab Sample is no longer allowed.

Automatically Set Amount & Amount Unit on Spec Execution Sample Action

Amount and Amount Unit values are now automatically set on Spec Execution Sample Actions from the related Spec Data Sample Action.

Block Reopening Tests on Imported Batches Instead of Blocking Reopening Spec Exes

In this release, we are relaxing the limitation that blocks the reopening of a Batch Release Spec Execution that has results being used by a Stability Initial Timepoint’s Spec Execution. Moving forward, users can reopen the approved Batch Release Spec Execution; however, the system blocks Tests from being reopened unless the Stability Initial Timepoint’s Spec Execution is reopened first.

Block Users from Updating Object Type of a Runtime Result

With this release, users are no longer able to update the object type of a Lab Test Result after its created.

Create Variation Result Action Excludes Certain Result Records

The Create Variation Result action no longer shows Results with Aggregate Variables or Cross-Test Variables.

Disallow Updating Batch on Spec Execution After Initiation

With this release, users can no longer update a Spec Execution’s Batch after the Spec Execution has been initiated.

Disallow Updating Material on Batch After Spec Execution Initiation

With this release, users can no longer update the Material of a Batch after at least one of the Batch’s related Spec Executions has been initiated.

Enhanced Validation to Prevent Loops with Calculated Results

When a Spec Data is made effective, the system now performs an additional check to ensure that there are no loops with Calculated Results that could prevent a Test from being completed.

Lab Sample: Select Sample Action Automatically Set

When a user manually sets the Selected Sample field on a Spec Execution Sample Action of type Select, the Spec Execution Sample Action field on the Sample record now automatically references that Spec Execution Sample Action record.

This was already done with AutoMatch set to Yes. With this release, it also occurs when AutoMatch is set to No.

Merge Evaluated Value Cells Across Timepoints

With this release, if Study, Test Definition, Result Definition, and Criteria Formula all match for a given Condition/Orientation combination, the system merges the evaluated value cells across each Timepoint in the report.

Picklist Value Inactivation

Picklist values for the following picklists can be inactivated: Sample Type, LIMS Criteria Indication, Sampling Point, Collection Type, Core ID Population Choices, Notation, LIMS Precision Type, LIMS Criteria Purpose, Rounding Rule, and Evaluate Option.

Prevent Duplicate Documents from Being Added to Test Definitions & Test Sets

The same document and version combination cannot be added to the same Test Definition or Test Set more than once.

Sibling Check Related Record State Change Entry Action Available in LIMS

The Sibling Check Related Record State Change entry action, which allows the action to execute based on the lifecycle state of sibling records, is now available in LIMS Vaults. Previously, this action was only available in Quality Vaults.

Spec Data Object Type Can No Longer Be Changed

Once a Spec Data is created with a certain object type, its object type cannot be changed.

Support for Generate Document from Formatted Output Actions in LIMS

With this release, LIMS now supports the Generate Document from Formatted Output action as both a User Action and an Entry Action. Both actions can be added in LIMS Vaults.

Test Definition Document Field Can Be Made Inactive

The test_execution_document__v field on Test Definition can be made inactive if the field will no longer be used.

Test Execution: Instrument Integration Enhancements

In this release, we are improving the experience of using integrated instruments during Test Execution. Users can trigger requests for data from instruments directly from a Result or manage them through a separate integration partner URL. Enable this feature by creating a relationship between integrated Inputs and Result Definitions within the Test Definition.

Test Set: Updated UI for Ordering Samples

With this update, we have made several minor User Interface improvements for ordering and reordering Samples in a Test Set including updating the Drag & Drop styling.

Timepoint Zero Use Batch Results: Sort & Filter Sample & Sample Type

In this release, we are adding sorting and filtering capability to the Sample and Sample Type columns of the match selection grid in the popup dialog when selecting Batch Release Tests to use for a Stability Study’s Initial Timepoint.

Update Expected User Permission for Certain Objects

Users are now only required to have Read object permission for the following objects:

• Criteria Evaluation Set
• Criteria Evaluation History
• Lab Investigation Request

Updated Indication Picklist

For Test Definition Criteria of type Operational Criteria, the data model is updated to only include Alert as a value for Indication.

Warn If Spec Data Not Found During Batch Create

When a Batch is created, users are now informed if Spec Data cannot be found for the Batch’s Material/Country/Organization and can choose to proceed or cancel Batch creation.

QMS

Supplier Risk Assessment

This release introduces a new feature that is applicable to organizations that use Veeva QMS for Supplier Quality Management and Quality Risk Management. A new Risk Assessment type called Risk Factor allows customers to perform a Risk Ranking and Filtering (RFF) assessment for their suppliers. Risk Factor Assessments are often used to identify and rank inherent and performance-based supplier risks while onboarding a new supplier, during supplier periodic evaluations, and during the qualification and requalification process. Risk Factor Assessments can also be used outside the context of Supplier Quality Management if desired, for a product, material, process, site, and so on.

A Risk Factor Assessment provides a Suggested Risk Level value for a supplier based on a calculated Assessment Score. The screenshot below shows a supplier Risk Factor Assessment with a suggested risk level based on its assessment score.

A Risk Factor Assessment uses a Risk Factor Template to define risk levels for a range of assessment scores. Risk levels have Maximum Threshold Values that define the maximum assessment score for a particular risk level.

The Risk Factor Assessment shown above automatically assigned a Medium suggested risk level because its assessment score (36) is greater than the Low risk level’s maximum threshold value (20), and less than the Medium risk level’s maximum threshold value (40).

An assessment score is automatically calculated from all of the Risk Factor Scoring records in a Risk Factor Assessment. The screenshot below shows the assessment’s Risk Factor Scoring records.

Each scoring record identifies a Risk Factor Category and an associated Risk Factor within the category. A user performing this assessment selects one of the available risk factors for each category.

Inside a category, each risk factor has a Risk Factor Value. The screenshot below shows a category and each of its risk factors and values. It also shows a category’s Weightage, which affects a risk assessment’s scoring, as you will see in a moment.

In a Risk Factor Assessment, when a user selects a risk factor, Vault automatically copies the associated risk factor value and category weight to the corresponding fields in the Risk Factor Scoring record, and multiplies the two to calculate a score for each risk factor as shown below.

All of the scoring records’ Risk Factor Scores are used to derive the Risk Factor Assessment’s score. Users must refresh the screen to see the new score after adding, removing, or changing a risk factor. The assessment’s template contains a Scoring Method to define how the score is computed, either as a sum or an average of all the risk factor scores.

Although Vault automatically calculates a suggested risk level, this feature provides a Final Risk Classification field to allow a user to manually override the calculated level if necessary.

Now that we know about the components of a Risk Factor Assessment, and how they are used to calculate the assessment score and suggested risk level, let’s examine how Risk Factor Scoring records are created.

After a template is assigned to an assessment, Vault automatically creates one Risk Factor Scoring record for every Risk Factor Category in the template. Templates drastically decrease the time and effort required to prepare a Risk Factor Assessment. Business Admins create and approve templates on behalf of users that perform assessments. Once a Risk Factor Template is assigned to an assessment, it is not recommended to change the template. However, if your organization allows this, Vault creates new Risk Factor Scoring records for any new categories that did not exist in the original template, and it will not modify any existing Risk Factor Scoring records that already existed from the previously used template.

Users with permission can also manually create a Risk Factor Scoring record directly from within the assessment using the Create button. This is useful when a template is updated to include new categories and risk factors after the template is assigned to an assessment.

Business Admins can maintain Risk Factor Templates, making updates to them as needed. When a template is updated, it does not affect in-progress or closed assessments using the template.

This feature requires configuration by an Admin after the release in order to utilize it. Also note that because Risk Factor Assessments are fundamentally different from other risk assessment types, they do not use the Risk Builder, Heatmap or Assessment History features.

Learn more about working with supplier Risk Factor Assessments.

External Collaboration: Qualification & Organization Questionnaires

The External Collaboration feature empowers customers to seamlessly manage interactions with external partners. It provides designated contacts from partner organizations with temporary access to a Vault in order to receive and complete tasks. Once tasks are completed, their access to the Vault is automatically revoked, ensuring security and efficiency.

With this release, External Collaboration functionality is expanded to Organization and Qualification records. This allows customers to send external partners tasks to complete questionnaires instantiated from Organization and Qualification records using the Veeva Vault Platform Checklist functionality. Organizations can use checklist questionnaires during the qualification and requalification process to gather comprehensive information about a supplier’s capabilities, quality management system, compliance, and overall reliability. This feature provides a robust tool for enhancing communication and data gathering with your external contacts.

The screenshots below show an external collaborator’s user experience receiving a task to complete a checklist questionnaire for an initial qualification to become a material supplier.

Checklist questionnaires are designed and approved by your Business Admin before use, ensuring that they meet your specific organizational needs. Learn more about working with checklists. Prior to sending a checklist questionnaire to an external partner, Admins must configure the External Collaboration feature. Learn more about configuring External Collaboration for checklist questionnaires.

Audit Room: Nudge Notifications

This release introduces the ability for Audit Room users to message assignees of Inspection Requests directly from the Audit Room application page, facilitating faster, clearer, and templatized communication in the high-stress environment of an inspection or audit.

Organizations can choose from a selection of predefined template communications to be sent directly to the assignee of any given Inspection Request within the Audit Room.

The message template selected acts as a quick start for the communication, but once selected, it can easily be changed to suit the needs of the moment.

These messages are sent immediately to the assignee as a Notification and an Email, so you can be sure even if they’re not actively logged in to the Vault, they will receive the message that action is required from them.

Additionally, via the mail icon in the Audit Room, any member of the Audit Room may send a nudge to all Assignees of any Inspection Requests in the inspection by using filters on the Inspection Requests. For example, a nudge indicating Attention Required could be sent to the Assignees of all Priority = Medium and Category = Training in progress Inspection Request records. Each matching Assignee will get this notification rendered with any tokens pertaining to each Inspection Request that they are assigned to.

This feature is automatically enabled for Vaults with Audit Room configured. Learn more about managing inspections in Audits with the Audit Room.

Audit Room: Group Nudge Notification

This release introduces the ability for Audit Room users to message one or more individual Vault users about Inspection Requests that require their attention, regardless of whether those users are currently members of the Fulfiller or Front Office roles in the inspection, by using templatized messages for fast, efficient, clear, and specific communication during inspections and audits.

For Inspection Requests that have not yet been Assigned, members of the Audit Room will notice a new gesture available to them on the Inspection Request card within the Audit Room: Nudge Group.

Selecting Nudge Group will guide the user to select one or more Vault users from any Full User who is licensed for the QMS application and to select a message template (defaulting to Group Assignment for an Inspection Request) to send to them. This message may be modified to fit the needs of the moment or can be restored to the original template via the Restore Default gesture.

Vault users nudged in this way will be automatically added to the new Inspection Group Fulfillers role on the individual Inspection Request record, and thus are able to assign themselves as the Assignee for that Inspection Request and perform actions on that record per security configured for that role on Inspection Requests.

These messages are sent immediately to the Assignee as a Notification and an Email, so you can be sure even if the recipients are not actively logged in to Vault, they will receive the message that action is required from them.

This feature is automatically enabled for Vaults with Audit Room configured. Learn more about managing inspections and audits with the Audit Room.

Action Path Enhancements: Improved Flexibility & UI

This feature introduces several enhancements to the user experience for users working with Action Paths.

Multiple Action Paths for an Object Type

Currently, an object type is restricted to a single Action Path configuration. This is quite limited for customers using the Change Control object type on the Quality Event object. They can only define one Action Path process per Change Control object type.

This enhancement allows Quality Event Change Control customers to create different Action Paths for different kinds of Change Controls.

This enhancement is also helpful when an organization wants to change the way its Action Path is defined. Since an Action Path cannot be reconfigured once a record that uses it exists, this enhancement will allow customers to create a new Action Path for use with new records.

Defining multiple Action Paths for an object type requires configuration by a System Admin.

Editing a Change Action’s Action Step Directly Within an Action Step Section

This release will enable users to modify a Change Action’s assigned Action Step directly from an Action Step’s grid view as shown below.

In order to see the Change Action in the new Action Step, users should collapse and reopen the Action Step where the Change Action was moved, or refresh their browser screen and reopen the Action Steps.

Enabling this capability requires configuration by a System Admin by granting View permission to the Valid Action Step Column object control on the Change Action object in the permission sets associated with the users who create and edit Change Actions. The screenshot below shows this configuration in the QMS: Change Control permission set.

Note: The Valid Action Step Column object control appears in PDFs that are created using Download as PDF on Change Controls and Change Plans where Action Paths are used.

Allow Admins to Hide the Other Actions Section

The Action Path feature automatically adds a section called Other Actions to a Change Control record. This section allows users to add ad hoc Change Actions outside of Action Steps.

The Other Actions section is intended to cover situations where an organization identifies the need for a Change Action after the appropriate Action Step is Complete. The Other Actions section can also be used for Change Actions that don’t need to be sequenced.

Beginning in this release, customers that don’t want to deploy Action Paths with the Other Actions section can now hide it. Hiding the Other Actions section requires configuration by a System Admin using the option shown in the screenshot below.

If a user attempts to remove a Change Action’s Action Step without assigning another Action Step, and the Other Actions section is hidden, Vault will throw an error message indicating an Action Step is required.

Allow Users to Add Change Actions to an In Progress Action Step

Currently, Change Actions can only be added to Action Steps that have an Open status. When an Action Step moves to an In Progress status, the Action Step’s Create button is removed, preventing users from creating new Change Actions. Users also cannot select an In Progress or Complete Action Path when editing a Change Action’s fields.

Beginning in this release, users will now be able to add Change Actions to an In Progress Action Step. The screenshot below shows the Create button is available for an In Progress Action Step.

Users can also edit a Change Action’s field and select an In Progress or Open Action Step. Allowing users to add Change Actions to an In Progress Action Step requires configuration by a System Admin using the option shown in the screenshot below.

Allow Admins to Set Default Columns in Action Steps

This release allows Admins to configure default columns for Action Steps.

Setting default columns for Action Steps requires configuration by a System Admin, as shown in the screenshot below.

When users modify what is displayed in an Action Step by adding or removing columns, changing the column order, adjusting column widths, or sorting specific columns, Vault saves these modifications as their own personal user preferences. Personal user preferences override the default display settings defined by a System Admin. Users can always adjust their Action Step display to revert to the current default settings by clicking the Restore defaults link shown in the screenshot below.

Action Path Enhancements: Only Complete In Progress Action Steps

When a Change Control is in the planning stage, users add Change Actions to Action Steps that have an Open status. If a user cancels or deletes the only Change Action in the first Open Action Step, Vault automatically moves that Action Step to Complete. This prematurely activates the Change Control’s next Action Step. But if the next Action Step does not have any Change Actions defined yet, Vault moves it to Complete as well. This can repeat until all of the Action Steps are completed without ever executing a Change Action.

In order to correct this behavior, Action Steps will no longer move to the Complete status from the Open status. Beginning in this release, only In Progress Action Steps can be moved to Complete.

This feature is automatically enabled by the release, but it only impacts customers that are already using the Action Path feature. Users will see this change immediately, without any configuration by a System Admin.

Reason for Change: Support for Inline Edits

The Reason for Change feature enables an Admin to configure Vault QMS to require a reason for change when users edit specific fields on records in particular states. Vault captures the name of the updated fields governed by a Reason for Change configuration, the reason for the change specified by a user, the old and new field values, the user who makes the change, and when the change was made.

Prior to this release, when users edited fields in a list of records, and those fields were controlled by a Reason for Change configuration, Vault did not enforce the collection of a reason for the updates. A reason for change was only required when users edited fields from a record’s detail page shown below.

Beginning in this release, if a Reason for Change configuration already exists, Vault will automatically require a reason when a user edits one of the controlled fields in a list of records.

This feature is automatically enabled in all Vaults, but there is no impact if your Vault does not have the Reason for Change feature configured prior to this release.

Learn more about providing a reason for change.

Quality Teams: User Name Hovercard

This feature adds hovercards to Quality Team members’ names, providing related user information.

Admins can configure which fields are displayed by selecting the Display in default lists and hovercards option for fields on the User object. This feature is automatically enabled by this release, which means hovercards will automatically appear when a user hovers on a Quality Team member’s name, showing all User object fields configured to display in default lists and hovercards.

Reassign External Collaborator on Checklists

Organizations often encounter situations where an assigned external collaborator becomes unavailable for an active workflow task. Until now, it was not possible to reassign external collaborators on checklists linked to these workflow tasks. This disrupted critical business operations that rely on external partners completing checklist questionnaires, such as pre-audit assessments or supplier qualifications.

With this release, the Reassign External Collaborator feature now supports the reassignment of external collaborators on both the workflow task associated with an object record, and on any associated in-progress checklists. This crucial enhancement ensures uninterrupted execution of external partner workflows, particularly for processes involving checklist questionnaires.

Upon execution of the Reassign External Collaborator action, Vault prompts the user performing the reassignment to select a new external collaborator.

The newly selected external collaborator is assigned to the associated checklist’s active workflow task, and becomes the new targeted respondent for the in-progress checklist.

Vault also updates the External Collaborator field on the checklist’s parent record.

Enabling this expanded reassignment capability for both workflow tasks and their associated checklists requires configuration by an Admin. Admins can configure the Reassign External Collaborator action to include checklist reassignment on any lifecycle of objects supported for External Collaboration.

Learn more about reassigning checklists to external collaborators and configuring external collaboration checklist reassignment in Vault Help.

Record Check & Suggestions: New Configuration Options

This feature introduces new configuration options for Recurrence Checks, Duplicate Checks, and Suggestions that must be enabled by a System Admin.

New Configuration Option for Record Checks

Vault displays similarity scores on the Record Check Result pages for Recurrence Check and Duplicate Check. This release introduces a new configuration option for System Admins to hide the scores and simply display the labels for each of the matching tiers. In addition, a new picklist defines the default labels for each of the tiers (Likely Match, Possible Match, and Unlikely Match), but the labels can be modified by an Admin. The screenshot below shows a Recurrence Check results screen with and without the scores.

Hiding scores is also available for Duplicate Checks. Note that this configuration option is specified on each individual Recurrence Check and Duplicate Check configuration. Admins should consider selecting the same option across all Record Check configurations to ensure a consistent user experience. The screenshot below shows the System Admin configuration option for a Duplicate Check.

New Configuration Option for Suggestions & Record Checks

This release also introduces a new configuration option for System Admins to exclude alphanumeric values from system-generated match terms during Recurrence Check, Duplicate Check, and Suggestions features. The screenshot below displays the System Admin configuration option on a Recurrence Check configuration, along with the Help text that explains this option.

Note that this configuration option is specified on each individual Recurrence Check, Duplicate Check, and Suggestions configuration. Admins should consider selecting the same option across all configurations to ensure a consistent user experience.

Learn more about configuring Recurrence Checks, Duplicate Checks, and Suggestions for record field values.

Record Check & Suggestions: User Interface Enhancements

This release improves the user interface for Recurrence Check, Duplicate Check, and Generate Suggestions. The new user experience more clearly identifies all of the parameters used to find matching records. These changes are automatically enabled, and users will see them immediately, without any configuration by a System Admin.

The following screenshot shows the new Record Check user interface for a Recurrence Check.

The Match Terms section on the left includes the following controls:

• Match on Any of these Terms: Specifies the match terms used by a Record Check operation to be used when searching for matching records.
• Ignore these Suggested Terms: Specifies the match terms not to be used by a Record Check operation when searching for matching records.
• Text Comparison Fields: Specifies the text fields a Record Check operation uses when searching for matching terms.

The screenshot below shows match terms suggested by the Record Check operation in both the Match on Any of these Terms and Ignore these Suggested Terms controls. It also shows how User Terms, typed by a user, are displayed with a different background color (see the term container below).

Users can move match terms between the Match on Any of these Terms control and the Ignore these Suggested Terms control one at a time, by dragging and dropping a term, or through multi-selection. They can also click the x to ignore a match term and the plus (+) icon to add an ignored match term back into the list of terms. Suggested Terms and User Terms are displayed in the enhanced Record Check summary screen shown below.

The screenshots above focus on Recurrence Check, but the user experience is very similar for Duplicate Check. The example below is a screenshot of the user experience to initiate a Duplicate Check.

The screenshot below shows the enhanced user interface when initiating the Generate Suggestions feature for a record.

Learn more about working with Record Checks and Generating Suggestions for record field values.

Record Suggestion: New Record Suggestion Icon

The existing sparkle icon used to denote a Record Suggestion will now use a lightbulb icon.

Quality Record Checks with Non-Editable Prompts: Display Exact Match Field Values

For customers using Quality Record Checks with editable prompts turned off, exact Matching Fields now display corresponding values derived from the record being evaluated. The before and after images below demonstrate this change.

This feature is automatically enabled in this release.

Enable Auditing for Standard Legacy Migration Objects

We’ve updated the Legacy System Data data model objects to provide more control to customers who opt to bring this information into Veeva QMS. This feature allows Admins to turn on Auditing for the following standard objects:

• Legacy System
• Legacy Process Record
• Legacy Process Artifact
• Related Legacy Process Record

In prior releases, this function wasn’t available to Admins in the Vault UI. These changes unify the experience of viewing legacy and live records; both types of data now can display the Audit Trail user action, improving clarity and reinforcing consistency for Auditors reviewing legacy system information.

Field Corrective Action: Ingest Reply from External Persons

In this release, we are introducing a new feature that enhances the Field Corrective Actions (FCA) workflow by allowing recipients of External Notifications to reply directly to the notification email, with Vault automatically attaching the response to the corresponding Product Action record. This streamlines how acknowledgment forms, which are commonly returned via email, are processed by eliminating the need for manual handling. As a result, Vault ensures more accurate record-keeping, reduces manual tracking efforts, and improves overall process efficiency.

This functionality is especially critical during recalls or field actions, where acknowledgment from the Consignee is required to confirm a receipt of the notification and the agreement to take the appropriate action regarding the affected product.

QualityDocs

Streamlined Controlled Copy Reconciliation with Barcodes or QR Codes

A new page, Controlled Copies for Reconciliation, displays all active controlled copies.

Barcodes or QR codes can be placed in the header, footer, or margins, of the Controlled Copy overlay. These codes then can be scanned using a barcode/QR code scanner to automatically select the Controlled Copy Trace Records on the Controlled Copies for Reconciliation page. Users may also manually select multiple records on the page without a scanner.

Once the Controlled Copy Trace Records have been selected, the user can then invoke the Start Workflow dialog to send the records together on a multi-record workflow or perform a state change.

Dynamic Association of Process Navigator Documents Enhancement

As process owners create Document Association Criteria for a hierarchy within Process Navigator, they can preview the Vault Library documents included in the selected criteria. When the Preview includes at least one document matching the criteria, process owners can additionally download a CSV file that lists all dynamically-matched documents and includes details such as the document name, number, version, and lifecycle state.

Process Navigator Enhancements

User Preference for Preferred Visual Hierarchy Type Default in Process Navigator

Users are able to set their preferred default object type for the Process Navigator Landing Page, providing a more customized experience.

On the Process Navigator Homepage, a new Set Default Process Hierarchy button allows users to select a default object type for their Process Navigator Homepage. This preference overrides the default based on the Visual Hierarchy object’s default Object Type. When users do not set a user preference, Vault applies the existing default object type setting logic.

Process Navigator document links open in new tabs

Prior to this release, document links from Process Navigator Favourites and Details Pages will open in new pop up windows. In this enhancement, document links opened from Process Navigator Favorites and Detail Pages will open in new Tabs, making user experience consistent with opening document links from the Process Navigator Homepage.

Icon field Optional on Process Navigator Homepage for Root Parent Process

Prior to this release, the Icon field on the Process Navigator Homepage for a Root Parent Process was required. In this enhancement, users can create a root process without defining the Icon field, providing a consistent experience.

Manually associated documents with inactive Hierarchy Document records will not display in Process Navigator

In this enhancement, when a Hierarchy Document record is inactive, the corresponding manually-associated document will not be displayed in either the Process Navigator Homepage or the Process Navigator Detail Page. For dynamically-associated documents, as the dynamical association relationship is based on association rule instead of the Hierarchy Document record, dynamically-associated documents with a valid association rule will continue to display in both pages.

Automated Inactivation of Document Change Request & Periodic Review Records

Document Change Request and Periodic Review records are automatically closed when the associated Document Change Control (DCC) record is closed. This feature introduces the ability to similarly inactivate Document Change Request (DCR) and Periodic Review records when a document reaches its steady state and is not associated with a DCC. This can be especially useful in the case where Document Change Requests and/or Periodic Reviews are used to manage documents that are assigned to a lifecycle that does not use the Document Change Control feature (most typically those using the Draft to Approved lifecycle), or in cases where the Document Change Control object is not used at all in the QualityDocs application to manage document changes.

This automated closure is achieved by two document lifecycle entry actions: Inactivate Associated Document Change Request Records and Inactivate Associated Periodic Review Records. Both actions allow Admins to specify one or more states that a document’s related Document Change Request or Periodic Review record must be in for it to be inactivated (the action’s configured Source State), as well as the inactive state (the Destination State). When a Source State is not configured, Vault automatically transitions all DCRs and/or the Periodic Review associated with the target document to the Destination State.

Quality Relationships Panel: Document Change Request Section Enhancement

Users are able to view the Description when they hover over a Document Change Request (DCR) record in the DCR section of the Quality Relationships panel.

Ability to Disable the Relationships Panel

An Application Setting checkbox allows Admins to disable the standard Document Relationship panel to help avoid user confusion and redundancy if using the Document Relationships section in the Quality Relationships panel.

Document Control Homepage: Custom Filters

The feature allows Document Control users to filter the data in each Document Control Homepage process section (Document Change Controls, Periodic Reviews, Controlled Copies, and Documents with Upcoming Periodic Reviews) in both the landing page and the expanded views.

A filter option will be available for each of the sections of the Document Control Homepage, where users pick from a list of fields that they have access to for that given section. Once the filters are saved, Vault filters records accordingly.

The data filter will persist throughout the user session but resets upon logout.

External Collaboration Enhancement

The Download Document permission is available on the QDocs: External Collaborator permission set that is assigned to the QualityDocs External Collaborator application role. Enabling the Download Source permission in a lifecycle state security settings provides the External Collaborator with the access to download a copy of the source document while it is in that state.

Station Manager

Station Manager: Tabbed View of Documents

The Station Manager user is able to open up to 10 documents in a tabbed view on the document page of the Station Manager application for both iOS and Android. This enables the user to quickly select and open multiple documents, and to easily navigate between them.

Operating System Information Tracking in Station Device Records

Station Device records display the Operating System and the Operating System version of the devices running the iOS Station Manager or Android Station Manager applications.

Surveillance

eMDR: Gateway Certificate Only Authentication

With this release, Veeva has simplified the FDA Electronic Submissions Gateway connection flow for eMDR submissions, eliminating the need to provision a dedicated username and password in order to establish the Submissions Gateway.

The previous flow required both your team and the health authority to generate certificates and swap and upload them. It then required your organization to subsequently share both a URL and a username and password with the FDA. This new feature removes the requirement to provision and manage a bespoke user account for the FDA entirely.

Enablement is easy, and adoption is encouraged. The new flow can be enabled via Admin by selecting the FDA eMDR Gateway Certification Only Authentication checkbox under Admin > Settings.

Selecting this checkbox will update your Vault’s Gateway URL, which then must be shared with the FDA to establish the Gateway connection. Your Vault-specific URL can be accessed in Admin > Settings > Gateway Profiles, as shown below.

To support a simpler adoption flow, after changing to the new approach, your Vault will continue to process information sent to either the new or old gateway URL until the FDA confirms that they’ve received your new gateway information and incorporated it into your communications.

VPS: Adverse Event Report Due Date Calculation Improvements

With this release, the calculation of due dates for adverse events will now more intelligently account for the latest date upon which material information was received (for example, information that changes the Reportability Assessment of the adverse event), providing a more accurate direction for when the Adverse Event Report (AER) is due.

To better illustrate this, consider the following scenario of events:

• April 5: A Complaint is reported, so you run a Reportability Assessment, and find that the event is not reportable.
• April 15: You receive updated event information and rerun the Reportability Assessment, but this time find that the event is reportable.

Prior to this release, your Vault would provide you an AER due date based on the Awareness Date of April 5, even though you only learned that the event was reportable on April 15, so if the timeline should have been 30 days to submit the report (based on your Reportability Decision Rules), your Vault would indicate that you only had about half that time left to process the AER. This could lead to unnecessary urgency or mistakes.

With this release, given that same scenario, Veeva Product Surveillance will now review and understand that the new Latest Info Available field was updated to April 15 and base the 30-day submission timeline on that date, providing your teams with the most accurate representation of the actual reportability deadline for this event.

Enablement is automatic, though no behavior will change for records that do not yet have a Latest Info Available value populated. Learn more about Reportability Assessments.

PMDA: Truncation & Validation Rules Update

In line with continued investment for PMDA support introduced in 25R1, in this release we are updating the truncation rules to better align with health authority specifications. These improvements ensure a better user experience and greater compliance with PMDA requirements.

VPS: Adverse Event Report PDF Text Wrapping

Adverse Event Reports (AERs) are now better able to display text in various locations throughout the report, taking advantage of wider text areas where possible.

In prior releases, the AER PDFs were rendered attempting to maximize format compatibility by artificially structuring text so that it appeared to not fill an entire available section. This could lead to vertically longer reports than were otherwise needed and generally appeared messier than necessary.

In this release, Vault will more intelligently utilize the space available across the generated PDFs, leading to a sleeker, cleaner and shorter generated PDF.

This feature is automatically enabled and will take effect upon the next PDF generation for any given report.

VPS: Previous Report Field Provisioning

In support of an upcoming feature, all Vaults with the Adverse Event Report (AER) object enabled will have the Previous Report field added to them in an Active state. While this field will be present in all Vaults with the AER object, this field will not be populated with data by the system until a future release.

Training

Training Change Request

This feature enables the creation of requests to make changes to training and the Training Matrix. It is designed to allow users to submit requests for changes that can be implemented automatically at a specific time, eliminating the need for a Training Admin to manually create records. The feature also aims to improve the Document Owner user experience during the Training Requirement Impact Assessment process.

Before this feature, customers typically used a less formalized process for requesting training changes. Common solutions included ticketing systems like ServiceNow, forms, or custom Vault solutions, such as a custom Training Change Request (TCR) or Training Needs Assessment (TNA) object. Some customers even used their own custom external systems to manage this need.

This feature benefits Vault users in various training tasks such as:

• Document Owners can request that a new Training Requirement be added to existing curricula as part of a document change process.
• Managers can request that a Learner be added to a Learner Role.
• Department Representatives can request modifications to their department’s Curricula.

Additional aspects of this feature include:

• Automated Implementation: An hourly job automatically implements changes defined in a Training Change Request (TCR).
• Wizard-Based Creation: The feature utilizes a wizard-based UI for creating both Training Change Requests and individual Matrix Change Items.
• Automatic Change Descriptions: When Vault creates a Matrix Change Item, it automatically generates a change description to easily explain the requested action.
• TRIA Integration: The ability to request changes to the training matrix can be raised from a Training Requirement Impact Assessment (TRIA) record, creating a Training Change Request in the background.

Display Latest Steady State Documents on Learner Task Page

With this feature, Learners can view the latest Steady State document related to a completed Training Assignment in the History tab. Previously, when accessing documents through the History tab, a superseded document would cause Learners to encounter a “Document Not Found” error.

This feature provides Learners the ability to look back at previously completed training and access the current related document. This can be used as a way to quickly access the Library directly from assignments that the Learner knows they have already completed.

• Vault presents the Learner with the latest Steady State document.
• A message is displayed telling the user which document version they actually trained on, as well as the version they are currently viewing.

Training Homepages: Export Functionality

This feature enables Learners to export data from the Open and History tab as a CSV document. Previously, the History tab could only be exported as a PDF. These documents can also be exported from the My Team page by the Learner’s Manager.

• The data exported is based on the current page filters.
• In the My Teams tab, the assignments of the Open, Completed, and All tabs can be exported to CSV.

My Learning Tab: Announcements

A new Announcements area is being added to the My Learning page. Customers can use it as a communication channel for training-focused messaging, helping to deliver important internal campaigns or compliance reminders directly where Learners engage.

Training Admins with appropriate access can create announcements with a title, message, start/end date, and conditions based on Person or Learner Role fields. They can also edit and delete the announcements.

For Learners, announcements appear as cards at the top of the My Learning page. Up to ten active announcements rotate every 20 seconds. Learners can manually navigate between announcements or jump to specific ones. Learners may hide the announcement area until their next log-in.

Self Enrollment & Direct Assignment: No Due Date Option

This feature enables Training Administrators to choose due date options for Direct Assignments and Self-Enrollment assignments. This includes setting a specific due date or no due date for those types of assignments. Prior to this feature, Training Assignments created via Direct Assignment or Self-Enrollment were required to have a Due Date.

The ability to not set a Due Date allows Training Administrators to assign training that can be treated as optional. For example, a Learner may want to complete cross-training in another work area, but it is not a requirement for their job at the current time.

• Training Requirement has a new Self Enrollment Duration Option field which allows selection of either Self Enrollment Duration (with Duration and Unit fields required) or No Due Date.
• Training Requirements can now have a specific Self-Enrollment Due Date which is different from the Training Requirement Due Date.
• Due Date is now optional for Direct Assignments.
• In the Open tab of the My Learning page, Learners can filter their Training Assignments by no due date.
• In addition to the Overdue, Due Soon, and Due Later categories of the Open tab, Learners can also see the number of assignments without a due date.

TRIA Execution Date Migration

In 25R1, we released the Reconcile Retraining with TRIA Decisions feature, which included a new Execution Date field on the Training Requirement Impact Assessment (TRIA) object. This important field is used to compare with the latest completed assignment date to support retraining decisions. Following the 25R1 release, Vault began populating the Execution Dates for new TRIA records only, based on when the TRIA workflow was complete.

This enhancement automatically updates all existing TRIA records with a blank Execution Date at the time the Vault is upgraded. The field will be populated with the date when the latest TRIA workflow is completed. The system will use this field value for newer features, such as whether to assign the full training when creating Delta Training and Refresher Training rules.

Veeva Training Enhancements

Learner Homepage: Message for Forthcoming Assignments on the Open Tab

In situations when a Learner is still being processed for new Training Assignments, Vault displays the following message: “You do not have any Training assigned right now. It may be in the process of being assigned. Please check again later.”

This communicates to the Learner that they likely have new Training Assignments coming that have not been processed yet.

Previously, the message was “No Tasks are currently assigned to you.”

Training Assignment stock image color contrast

For various types of assignments, the current Veeva-provided stock images displayed on the Learner Homepage and Curriculum and Learner Role detail pages have a low color contrast when displayed on a white background. To improve accessibility to meet WCAG requirements, these stock images are updated with a new set of colors for greater color contrast.

Learner Role Detail Page progress bar color contrast

The progress bar on the Learner Role detail page currently displays information in a light gray color, which presents a low contrast to the user. The bar and related text are now updated with a darker color to give greater contrast according to WCAG requirements.

Overdue, Due Soon, and Due Later colors on all Training and Study Training pages

The red, orange, and green indicators are updated to different shades of those same colors, in order to provide greater contrast to the user. Note that some areas must be updated by platform, such as the Learner Task Page.

New Regulatory Bulletin Course Type

This enhancement adds a new Regulatory Bulletin value to help better identify such courses via the learngxp_course_type__v and course_type__v picklists.

Learner Homepage: Curriculum and Learner Role Page Images

For a Curriculum, Vault will display the course image for the most overdue Training Assignment. If this assignment is a LearnGxP course, Vault will display the Learner Homepage Image.

For a Learner Role, Vault will display the first Training Assignment that has an image. If the assignment is a LearnGxP course, Vault will display the Learner Homepage Image.

For both scenarios to apply:

• An assignment cannot be the result of a Direct Assignment or Self-Enrollment.
• A Curriculum does not already have a configured Learner Homepage card image

Notification of Class Open for Self-Registration

When a class is open for self-registration, Vault sends Learners a notification so they can self-register.

This occurs when a Class Schedule is created or updated with its Self-Registration Status set to “Open for self-registration”. Vault sends the notification Learners with a related Training Assignment in the Assigned state and its Part of class field is No (false).

Notification of Quiz Issuance after a Class is completed

When a class is complete and a Classroom Training Assignment includes a quiz, Vault sends a notification to the Learners so they may complete the quiz. This behavior applies to Training Requirements and related assignments using the Instructor Led Training UI only.

Default sort order of Substitute Rules updated from alphabetical to specified order

Previously, the default sorting for Substitute Rules was by name. Rules will now be sorted by:

• Rule Type
• Substitution Type
• Priority
• Training Requirement

Hide access to Curriculum Matching and Dynamic Enrollment if user has no permissions

Previously, users without Read access to the Curriculum Matching Configuration Rules and Dynamic Enrollment Rules (in Permission Sets > [Permission Set] > Admin) were still able to view these components. These are now hidden from such users.

Validation Management

Reference Instruction Prompt

In 25R3, we’re introducing the Reference Instruction Prompt feature to address the challenges Test Authors often face when needing to convey complex visual information. Prior to this, Test Authors frequently had to embed long descriptions or rely on external links to include details like diagrams or layouts, which often led to confusion and wasted time.

This new feature allows Test Authors to add a reference by either uploading a single file directly from their local computer or by linking to an existing controlled document in Vault such as SOPs, work instructions, and so on. When a user uploads a file from local, the system automatically creates a new document and links it to the prompt. This not only makes authoring more efficient but also ensures that all critical references are centrally managed.

Admins can define the types of documents that can be used in Reference Instruction Prompts. This ensures consistency and adherence to your organizational standards. As shown in the screenshot below, Admins can easily define and manage these available document types, tailoring the options to your specific needs.

Test authors can easily add a Reference Instruction Prompt in the Test Authoring Interface. As you can see in this image, Test Authors have the option to either upload a file directly (for example, an image or a video) or select an existing document from Vault. When a local file is uploaded, the system automatically creates the document in Vault and establishes the link to the prompt, simplifying the authoring workflow.

We’ve also enhanced traceability for these linked documents. When a user accesses a document that is being referenced by a prompt, they will find a Quality Relationships panel. This panel clearly shows which Reference Instruction Prompts are using the document, providing a transparent “where-used” view, as illustrated here. This ensures you can always see how critical references are being utilized across your test procedures.

Ultimately, the Reference Instruction Prompt replaces multiple paragraphs of instructions with a single, clear visual reference, directly within the test context. This results in improved clarity, greater consistency, and a significant reduction in execution errors, ensuring everyone has immediate access to the critical information they need to get the job done right. This feature is enabled through configuration.

Optional Entity Versions

In 25R3, users will be able to manage non-versionable entities more efficiently through the ability to hide entity versions when they are not applicable to a Validation Entity. A new Entity Requirement app section can be added to Validation Entity page layouts, which will allow for the management of requirements at an entity level (leveraging the latest entity version identified for the Validation Entity). Additionally, a new Entity Version Field app control is also available and can be added to Validation Entity layouts, which will allow for the editing of Entity Version fields (either the Latest Entity Version or In-Use Entity Version) from the Validation Entity.

Through configuration, Admins will be able update layouts for the Validation Entity, Validation Activity, Validation Requirement, and so on, to only show Entity Version fields when appropriate, allowing for a more simplified user experience. This feature is enabled through configuration.

In-Scope Requirements & Specifications for Validation Activity

With the 25R3 release, this feature lets you define which requirements and specifications are in scope for a specific Validation Activity. This new capability is designed to give you greater clarity, focus, and traceability throughout your validation process.

This feature is auto-on because we’ve added a Validation Activity field to the Requirement Traceability Matrix object. If your Traceability Matrix records are already linked to Test Steps, the system will automatically populate the Validation Activity field with the Validation Activity that the Test Step is associated with. In turn, all Requirement Traceability Matrix records created after the release will have their Validation Activity value filled in by the system when a requirement is challenged, so no additional effort is required. As a result, you’ll immediately be able to see the requirements included in a particular activity directly from your Requirement Traceability Matrix reports.

While the new traceability feature is enabled by default, additional configuration is required to get the most out of it. To allow your users to view and manage requirements directly from an Validation Activity record, an Admin will need to modify the Validation Activity page layout and add the new Activity Requirements section as outlined below. With this section in place, users can perform key tasks directly on the Validation Activity record, such as creating new requirements, linking existing ones, and even excluding requirements that are no longer in scope. In addition to the page layout changes, there may also be some necessary permission settings that an Admin needs to update.

Enforce the Template Requirement Refactoring

With the release of 25R3, the refactoring of Template Requirements (introduced in 25R1, communicated in Q4 of 2024) will be enabled and enforced. All customers who have not yet enabled the new Template Requirement functionality will have it enabled as part of the 25R3 update, and existing Template Requirements will be migrated accordingly. This feature is auto-on.

Requirements Entity Version Section Improvements

In 25R3, users will see updated action labels in the Requirement Entity Version section. Add and Remove will be replaced with Link Requirements and Unlink Requirements to better differentiate them from Create.

Additionally, improved error messages and error handling has been added to provide more clarity to users when Atomic Security configurations prevent the creation of requirements or the linking and unlinking of requirements.

This feature is auto-on and visible for all users who interact with the Requirement Entity Version application section.

Regulatory

In addition to the below release notes, the RIM Registrations and RIM Submissions, Publishing, and Archive Veeva Connect communities offer general release communications, release highlights, and key feature demos.

The following features listed in the Veeva Connections section also affect the Regulatory application family:

• Quality-RIM Connection: Requires Correction State for Change Item
• RIM-Clinical Operations Connection: Updates to Submission Tracking for Clinical Trials
• Safety-RIM Connection: Reflect Accurate Deletions in Safety Vaults
• Safety-RIM Connection: Transfer All Valid Registrations

All RIM Applications

HAQ Response Automations

Responding to Health Authority Questions (HAQs) often involves a series of repetitive, manual tasks across different pages in Vault. This process can be needlessly time consuming for an activity that is typically time-sensitive. To address this, we’re introducing HAQ Response Automations, a new feature designed to streamline and simplify this entire process.

Now, with the new Initiate Response action, you can create a response record, start a submission, auto-generate a content plan, and create a response document—all from a single, guided flow.

What’s New?

• Health Authority Response (HAR) Object: We’ve added a new object to the RIM data model to help you track and plan your responses more effectively.
• New Fields on HAQ and HAQ Submission Objects: Health Authority Response, Response Document, and Response Document Order fields have been added to the HAQ object, and a Relation of Submission field has been added to the HAQ Submission object to identify the type of submission as it relates to the response.
• Initiate Response User Action: This new action, available on the HAQ tab, kicks off a guided process that walks you through refining your HAQ selection, creating or selecting an HAR record, and choosing the activities you want to initiate.
• Automated Response Document Generation: You can now automatically generate a response document from a template, with the option to reorder the HAQs to your liking.

How It Works

1. Select Your HAQs: From the HAQ tab, select the questions you want to address and click the Initiate Response action.

   

2. Guided Flow: A multi-step tool will guide you through the process, allowing you to:
   • Refine your HAQ selection.
   • Create a new HAR record or link to an existing one.
   • Choose to create or select an existing response submission, regulatory objective, content plan, and/or response document.
   • Reorder the HAQs for your response document.

   

3. Automated Actions: Once you complete the wizard, RIM takes care of the rest:
   • The HAR record is created and linked to the relevant Application, Regulatory Objective, and Submission.
   • The selected HAQs are updated with the HAR and response submission details.
   • A response document is generated and, if applicable, is matched into an auto-created content plan.
   • You’ll receive a notification when all activities are complete.

How to Get Started

This feature is automatically enabled in your Vault, but an Admin will need to complete a few configuration steps to get you up and running:

• New Application Settings: A new application setting, “Enable Initiate Response” is available under RIM settings, and should be enabled. A subsetting, “Select Response Templates” will support the selection of one or more formatted outputs configured in your Vault.
• Configure Lifecycle States: The Initiate Response user action must be configured on the applicable HAQ lifecycle states in order to be made available.
• Update Permissions: Grant users access to the new Initiate Response object action along with the new Health Authority Response objects and fields, and the new fields on Health Authority Question and HA Question Submission.
• Configure Page Layouts: Add the new HAR object, fields, and relationships to your page layouts.
• Set Up Response Document Templates: To enable the response document generation option, you’ll need to configure at least one response document type and a formatted output template.
• Configure the Response Document Types in the RIM Document Type Configuration admin page so that Initiate Response = Yes for each applicable leaf document type.
  • The following field must be configured onto the response document types:
    • Health Authority Response
  • In order for the document to be matched into the Content Plan, the following fields must also be configured on the response document types:
    • Application
    • Submission
  • We also recommend configuring the following fields onto the response document types:
    • Health Authority Response
    • Health Authority Questions
  • Note that the configured response document type must be an active leaf type. This means that it is the lowest level type/subtype/classification and there is no active child subtype/classification under it.

Additional Considerations

There is a limit of 1,000 HAQs that can be selected for Initiate Response. If there are more than 1,000 HAQs in the HAQ tab when the action is initiated, only the first 1,000 HAQs are included in a single run. Users will need to break up HAQ’s into batches of 1,000 or fewer for each run of the guided flow - we suggest using filters to break up questions into logical groups for each run when there are more than 1,000 HAQ’s in a response.

RIM Bot Prediction Metrics Enhancement

To give you a more current and granular view of RIM Bot activity, we have enhanced the frequency of how prediction metrics are updated.

Previously, prediction metrics were updated on a monthly basis. Now, these metrics will be updated daily, providing a more accurate and timely reflection of RIM Bot activity and performance.

Additionally, a new set of prediction metric records will now be created with each new release, rather than monthly. This change gives you a clearer view of bot performance over a release cycle and makes it easier to assess changes in accuracy from one release to the next.

RIM Publishing

European Union eCTD 3.2 Validation (EMA v8.2)

Veeva Publishing now supports the new EU eCTD M1 specification version 3.1.1 and validation criteria version 8.2.

The new validation criteria (v8.2) will be mandatory for all v3.1.1 electronic submissions to National Competent Authorities (NCAs) and EMA starting December 1, 2025.

The submission timeline is as follows:

• June 2, 2025 - September 30, 2025 (Initial Period): Only eCTD submissions compliant with EU M1 v3.1 and validation criteria v8.1 are accepted.
• From October 1, 2025: eCTDs compliant with either EU M1 v3.1 or v3.1.1, and validation criteria v8.1 or v8.2, will be accepted.
• From December 1, 2025: Only eCTDs compliant with EU M1 v3.1.1 and validation criteria v8.2 will be accepted.

EU publishing will require configuration to encompass the above changes, which can be provided to customers via VPK to aid in deployment.

Bosnia (BA) eCTD 3.2 Publishing & Validation (BA v3.1)

Veeva Publishing now supports Bosnia (BA) eCTD (ICH eCTD specification 3.2) based on the Bosnia Health Agency ALMBiH v3.1 DTD and regional specification v1.0.The Submission Administrative Information will be based on EU (EU version 3.0.1 and 3.1) with Bosnia- specific Controlled Vocabulary for the Regional DTD/XSD version only.

This feature uses the EU Content Plan Template and adapted EU DTD and validation criteria with region specific updates to support eCTD, including:

• country (ba)
• language (bs, sr)
• agency (BA-ALMBIH) codes.

Bosnia eCTD Publishing will require configuration which can be provided via VPK to aid deployment.

Tunisia eCTD 3.2 Publishing & Validation (TN v1.1)

Veeva Publishing now supports Tunisia eCTD (ICH eCTD specification 3.2) publishing and validation, based on the National Agency for Medicines and Health Products (ANMPS) regional specification package v1.1. Publishing customers can build eCTD Submission Content Plans including a new TN Module 1 template, include optional STFs or node extensions, publish compliant submissions per XSD v1.1, and validate per the ANMPS Validation Criteria v1.1.

Tunisia eCTD publishing will require configuration of the following, which can be provided to customers via VPK to aid in deployment:

• New Tunisia v1.1 Module 1 Content Plan Template
• New Controlled Vocabularies and Constraints for TN Application and Submission types/subtypes, Country/Health Authority, and DTD
• Validation Criteria v1.1 package
• Additional configuration for object Layouts

Japan eCTD 4.0 Validation (JP v1.6.0)

Veeva Publishing now supports Japan eCTD 4.0 submission validation, based on the Pharmaceuticals and Medical Devices Agency (PMDA) Validation Criteria v1.6.0.0. Deployment of new validation rules will ensure Japan eCTD 4.0 (JP 1.6.0) submissions generated by Veeva Publishing will be compliant.

A total of 377 validation are included in the Validation Version JP v1.6.0.0 (UUID 568b2f28-4717-403c-b387-9be7b80271a0): ICH general rules (will be reused in other regions) - 40 JP v1.6 specification-defined rules - 322 Additional Veeva-provided rules - 15

Impact

Rules will be executed upon initial, continuous, and on-demand publishing and validation when the Regional DTD/XSD value on the Submission record is JP 1.6.0 (eCTD 4.0) (UUID 568b2f28-4717-403c-b387-9be7b80271a0). Rule subsets will also be run based on the Category Event values for the submission.

Considerations

Configuration of Validation Criteria records and associated Data Model changes are required, and can be provided to customers via VPK to aid in deployment.

XML Operation Field Respects Default Value for eCTD 4.0 & EAEU Content Plan

To align with behaviour of CTD Content Plan Template creation, the XML Operation field on the Content Plan Item object will default to a blank value if the field has not been configured with a default value. Previously, upon creation of the EAEU and eCTD 4.0 Content Plans, the XML Operation field value would default to New instead of the preconfigured value or blank value. Now the value will be respected, consistent with Content Plan creation from other templates.

Validation Rule Enhancements

This release includes an enhancement to the validation rule. Previously, this rule would incorrectly generate a warning message if the manufacturer, substance, dosageform, or product-name XML attributes were empty. The system has been updated to treat an empty value for these specific attributes the same as a null value, therefore eliminating the validation warning.

Bring Forward Annotations for Keyword Links

When using Keyword Links for external document linking, users can now bring forward and move Approved or Auto-Accepted links that were created in a previous version of the link source. The action to move links will be available on the Annotation action menu for users with Annotation permissions on the available Lifecycle States:

Considerations

When using the Move action, auto-created Keyword Links will be converted to manual annotations. If an Auto-Link is brought forward onto a document version that does not contain matching text, the Auto-Link will be created as a page-level annotation. The page-level annotation does not have the option to be moved.

Auto-Return Bookmarks for Table of Contents

When a publishing job includes a system-generated Table of Contents (TOC), the system can now include a bookmark that returns the reviewer from the TOC target PDF back to the published parent TOC.

Key Changes

A new Return Bookmark Yes/No field on the Publishing Element, when configured and set to Yes, will direct the system to automatically create a return bookmark on target documents that are referenced in the system-generated TOC. Return bookmarks will appear at the top of the bookmarks pane in the published PDF file, and will assume the name of the TOC’s Content Plan Item (edl_item__v.title__v_). Bookmarks will not be added or updated on the Library source document that was matched to the CPI referenced in the TOC.

Impact

Auto-return bookmarks are available for TOCs in Submission Content Plans for non-eCTD submissions, and for TOCs generated in Report Level Content Plans. Bookmarks will only be added to PDF outputs.

Considerations

When CPI- or Section-level merged documents are included in a TOC, the merged published PDF will include a return bookmark. Root-level merged PDFs will not contain a return bookmark as the TOC would be included in the single PDF published output.

Submission TOCs should not be included in eCTD submissions, therefore return bookmarks will only be created for eCTD submissions if the xml_ich_dtd_xsd_version__v value on the Submission object record is set to “N/A (ICH)” (UUID b821be23-c535- 48be-b8ba-b840491bdb0a).

When the return bookmark is added to the target document in an EAEU submission, its checksum will be updated. The EAEU XML should be republished after TOC generation and the return bookmarks are added.

When an overall parent TOC references nested section-level TOCs, the nested TOCs will now include a return bookmark. If a target file is referenced within multiple TOCs, the target PDF will include multiple return bookmarks. When using the Edit Table of Contents functionality, auto-return bookmarks will not be displayed and cannot be edited.

Add Bookmark Level Column to Edit Table of Contents Page

A new column, Bookmark Level, is now available on the Edit Table of Contents page. Bookmark Level values will provide users a convenient reference to specify which level of bookmarks they want the Include Bookmarks to Defined Level action to include.

Impact

The new column display will be available for users of system-generated TOCs in Submission Content Plans and RLCPs.

Key Changes

Previously, the Level column on the Edit Table of Contents page did not apply to both bookmark actions. To improve the end user experience and reduce TOC editing rework, users can reference the bookmarks to be included in their TOC as follows:

Include bookmarks to defined level:

• Users can launch from the Root, Content Plan, or Content Plan Item level
• Users will reference the new Bookmark Level column, which includes filtering and an information dialog icon
• The value will correspond to the level the bookmark is away from its parent
• The information presented with more logical values (e.g., selecting ‘2’ will include Levels 1 & 2)

Include all to defined level:

• Users will continue to launch only from the Root level
• Users will continue reference the existing Level column and filters

Support Accurate Table of Contents Linking for Multiple CPI Matches

When the same source document in a Content Plan has been matched to multiple Content Plan Items, and each CPI has a unique Published Output Location value, the separate system-generated Table of Contents entries will link to each document individually.

Impact

This new TOC linking behavior is particularly valuable for non-eCTD submissions, where the same document may be matched to different sections with the intent of being published multiple times (instead of using Reference Leafs). The new linking behavior will also be reflected in RLCPs or eCTD SCPs where Reference Leafs are not in use.

Key Changes

While Reference Leaf creation is not used for non-eCTD submissions, previous iterations of the system-generated TOC did not reflect this difference and links could target any of the instances of the matched source file. With this release, TOC target links will more accurately reflect the published output.

Exclude Non-PDF Documents from Link Evaluator

As links are not published in non-PDF published output, non-PDF document links will no longer appear as actionable in Link Evaluator. Veeva Publishing does not modify source files when the Source of Published Document (SOPD) value is Source Document. Therefore, if non-PDF source documents contain external hyperlinks, link information that appeared previously was inactionable, and often inaccurate.

Key Changes

When the source of an external document hyperlink is a non-PDF document, the linking rules will appear as Not Executed. This new rule value more accurately reflects how SOPD Source files are handled by the system.

Link Evaluator results will be empty for non-PDF files that contain external hyperlinks, as these links can be neither suppressed nor retargeted.

RIM Publishing, RIM Submissions

Restrict Tokens for Use in Standard Notification Templates

Previously, some tokens were available for selection in notification templates where they were not supported. Using these tokens would cause them to fail to resolve in the final notification. With this update, the system now restricts the list of available tokens to only those that are supported for the specific notification template being edited. This ensures that any selected token will function as expected.

RIM Publishing, RIM Submissions Archive

Viewing Sender Defined eCTD 4.0 Keywords on Published Submissions

For eCTD 4.0 submissions, the Sender Keyword Hovercard will automatically display different values for the Code System OID based on the status of the first and subsequent published Submission records. The Code System OID will appear on all subsequent submissions, and for all Health Authority Keywords.

The changes observed with this feature only apply to the Keyword Hovercard display values. No changes have been made to the underlying system behavior used to calculate the different display values. The most recent Sender Keyword in the system shows in the top row of the Keyword Hovercard and drives the Keyword Hovercard Display Tooltip. The Hovercard and Tooltip scenarios are illustrated below:

Viewing eCTD 4.0 Keyword Optimization

To improve the eCTD 4.0 Submissions Archive Viewer experience, Health Authority eCTD Keywords will now be populated in grid cells of Selected Columns, and only for individual documents. The Viewer will not display content at the Section level. This provides essential context at the document level without adding redundant information or complicating the Viewer display unnecessarily.

Key Changes

Health Authority eCTD Keywords will be removed from Section-level rows and will only be displayed in grid cells at the document level.

Impact

These changes apply when using Submissions Archive Viewer to view published or imported eCTD 4.0 submissions.

System-Managed Data Made Read-Only

eCTD Metadata (ectd_metadata__v) object records can no longer be created, updated, or deleted from the Business Admin UI. Object fields are now read-only, preventing changes to data fields required for the proper display of imported or published submissions in Submissions Archive Viewer.

The eCTD Metadata object drives proper display and navigation of eCTD 4.0 submissions, particularly Priority Number and Document Title updates. The purpose of this feature is to protect customers from making changes that may result in significant downstream remediation efforts for their eCTD 4.0 submissions. This feature aligns with similar protective changes made to the Submission Metadata object in a previous release. Custom fields remain editable.

Key Changes

A new error message of “This operation is not supported. The data is read-only as it is system-managed.” is displayed when attempting to create, edit, or delete an eCTD Metadata record from the Business Admin UI.

Export API: Support for Published Submissions

The Submissions Archive Export API endpoint will now allow for export of submissions published by Veeva Publishing. Any archived submission, regardless of whether it was published in the system or imported into the system, can both be completed via the API. Published submissions with the following Dossier Status values can be exported:

• Publishing Active
• Publishing Inactive
• Transmission Failed
• Transmission Successful
• Transmission in Queue
• Transmission in Progress

Impact

Previously, Administrators and Developers were limited by this API gap. Existing user permissions for Submissions Archive export will be respected, and no additional permissions or settings are required. There is no maximum size of submissions being exported via the API.

RIM Registrations

EUDAMED Acceptance: Data Updates to Support Compliance

o help you maintain compliance with European Union Medical Device Regulation (EUDAMED), Vault now automatically creates and updates specific data records when a submission is accepted by a Health Authority. (Using the RIM Machine to Machine integration with EUDAMED or by manually setting the state to Accepted by Health Authority)

When a submission’s lifecycle state is set to Accepted by Health Authority, Vault automatically generates or updates Registered DI Countries and Registered DI Container Packages records where appropriate. It also updates the appropriate Device Identifier (DI) versions based on the submission’s type and the data in the accepted XML file. This automation reduces manual data entry and ensures your product registration data is accurate and up-to-date, so that you can more easily manage compliance.

The Registered DI Countries related to the Registered Device Identifier captures data related to the current version of the Market Information in EUDAMED for the device. The Registered DI Container Packages related to the Registered Device Identifier captures data related to the current version of the Marketing Status for Container Packages in EUDAMED for the device.

EUDAMED Container Packages Machine-to-Machine & Viewer Support

This feature extends Vault RIM’s EUDAMED submission capabilities to include container package submissions. You can now generate, review, and send device container package submissions for registered devices directly from Vault to EUDAMED using a machine-to-machine (M2M) connection. This provides a streamlined process to help you comply with EUDAMED requirements for device container package submissions.

EUDAMED Container Packages Submission Generation

Vault RIM users can now generate UDI-DI Container Packages submissions for medical devices registered in the European Union. This feature allows you to create compliant XML submissions for all levels of device packaging that are not the smallest unit of use, such as boxes or shipping containers.

When you add or update packaging information for a registered device, you can now generate a submission specifically for those container packages. In the Select UDI Submissions dialog, choose the new UDI-DI Container Packages option from the UDI Submission Type picklist. Vault automatically compiles all relevant package information from related registrations.

This feature also introduces the Enable default EUDAMED XML Version setting, providing the ability to set a default value for the XML Version when generating an EU UDI Submission. This replaces the manual effort of entering the XML Version when a newer version is required but there have been no XSD updates for UDI submissions. This feature saves you from manually entering a version for each submission and helps manage different version requirements for EUDAMED’s Playground and Veeva RIM environment, as XSD versions can differ.

EUDAMED Market Information Machine-to-Machine & Viewer Support

This feature extends Vault RIM’s EUDAMED submission capabilities to include Market Information submissions. You can now generate, review, and send Market Information submissions for registered devices directly from Vault to EUDAMED using a machine-to-machine (M2M) connection. This provides a streamlined process to help you comply with EUDAMED requirements for device marketing information.

Update Local Regulatory Information

This feature introduces a new method for updating existing regulatory records in bulk. Previously, while users could create records like Activities and Submissions in bulk from an Event, there was no equivalent function to modify those records when an event’s scope changed.

A new user action, Update Local Regulatory Information, is now available on the Event object to address this. It allows users to push new details to existing related records.

Functional Details

The Update Local Regulatory Information action is available from an Event record’s action menu and launches a wizard with the below capabilities.

Review Proposed Changes: Before committing, a screen displays all proposed updates. Users can review and deselect any details or records that should not be changed.

• Intelligent Selection Logic: Update Local Regulatory Information automatically pre-selects only new or modified details. This prevents redundant updates to records that have already been synchronized with the latest Event information. For example, if the Create Related Records action was run for a new market after a detail was added, the wizard does not re-select that market for the same update.
• New Tracking Fields: To support the selection logic, two new date/time fields have been added:
  • Local Regulatory Info Last Created on the Event object.
  • Last Sent to Impacted Markets on relevant Event relationship objects.

Configuration

To use this feature, an Admin must perform the following configuration:

1. Enable the Enable updating of local regulatory information Application Setting.
2. Optional: Configure sub-settings to restrict updates on records that have reached certain lifecycle states. This can prevent changes to records that have already been finalized or submitted.
   • Exclude activities in the following states
   • Exclude Submissions in the following states
   • Exclude regulatory objectives in the following states
3. Configure the Update Local Regulatory Information action for the Event object type.
4. Ensure users have permission to run the Update Local Regulatory Information action.

Grouping of Change Items

Change Items, introduced in RIM in 24R3, and the Quality-RIM Connection feature Enhanced Change Control in 25R1, have made it possible to track changes at a more granular level. However, with that granularity can come an overwhelming number of records to assess and disposition. To users, there is a single change that involves many products and/or packagings (for example, a change to a manufacturing process), but RIM currently represents these changes as separate Change Item records that all have the same field values except for Product, Product Variant, and Packaging.

With this feature, a new Change Item object type groups together otherwise similar product- and packaging-level Change Items. This greatly improves the user experience by letting users interact with change items at a much higher level with triggers to keep the group’s details in sync, while still providing the granularity needed for the Quality-RIM Connection.

The Change Item object’s new Change Item object type (change_item__v) is used to group together Change Item records of other types by Product Family. This provides information about the change and indicates which other areas need to be assessed by the local markets (CMC, Labeling, Artwork, Other).

Key Benefits

This approach significantly improves the user experience by:

• Streamlining Assessment: Users can now assess and disposition the change at the Product Family level.
• Ensuring Consistency: Key information is automatically synchronized from the grouped record down to all the individual items.
• Maintaining Granularity: The individual product- and packaging-level records are still maintained and linked to the group, preserving the detail required for the Quality-RIM Connection.

Enablement

This feature can be enabled with a new Group change items by Product Family Application Setting.

Impact Assessment Enhancements

This release includes enhancements designed to streamline and facilitate the management of the impact assessment process. The following changes provide new flexibility for administrators and improve the workflow for all users.

What’s New for Users

• Simplified Country Scoping (IARs): When you run an impact assessment report (IAR) from an Event and the Report Type includes the Registration > Country filter, Vault now automatically pre-populates that filter with the countries defined as Event Country records (the Event Country object was introduced in 25R2). This removes the need for manually filtering the report once created. You can still modify the list of countries to narrow the scope for a specific report run.
• Simplified Country Scoping (Create Related Records): When you run the Create Related Records action from an Event, the wizard automatically pre-populates the Event Countries. However, if you deselect all countries, the action is not limited to the Event Countries and will apply more broadly.
• Optional Prompts: You can now use IARs that include optional prompts, giving you more flexibility when running a report.

Areas for Admins to Consider

Admins have new opportunities to optimize their report configurations. Here are a few areas you may want to review:

• Look for opportunities to combine reports: Admins can review their existing IARs to see if multiple reports can be consolidated into a single one using optional prompts. This can help simplify the user experience and reduce the total number of reports to manage.
• Evaluate existing prompts: Consider whether any current reports with required prompts could be more flexible with an optional prompt.
• If you have the Registration > Country filter in your IAR Report Types: We recommend setting this filter as optional. This will allow the system to automatically pre-populate the countries from the Event Country records (if they exist) while still giving users the flexibility to manually adjust the country scope or skip the filter in the prompt.
• If you want to use the functionality related to the Event Country object: You must ensure the Registration > Country filter is included in your Report Types as an optional filter. You will also need to add the new Event Countries section to your Event object page layouts.

RIM Registrations, RIM Submissions

Create GCP from Active Dossier: Baseline from Application Support

To streamline the creation of new submissions, you can now create a Global Content Plan (GCP) as a baseline from a reference Application using documents from Active Dossier. This leverages the Active Dossier as a highly accurate source for the precise document versions that are Current for a reference application, significantly speeding up the initial document matching process.

The Challenge

When initiating global submissions, especially for subsequent markets (Wave 2) or variations to existing registrations, gathering the correct baseline documents can be time-consuming. While auto-matching from the Library is useful, it can overmatch or select incorrect versions, especially when multiple regional variations of a document exist. The Active Dossier often holds a more accurate, curated view of the exact documents and versions submitted and approved in a specific market. However, previously users could only leverage this by manually dragging and dropping documents.

Our Solution

A new user action, Create/Update Global Content Plan, allows you to use a reference application as a baseline. The system will automatically pull the current document versions from the corresponding Active Dossier and match them into the newly created GCP structure. This is particularly useful when using an initial application as a reference to submit in additional countries.

During the GCP creation process, you’ll be prompted to select a reference Country and Application. The system then uses the Event’s scope (Products, Substances, Inactive Ingredients, etc.) to filter the Active Dossier and map the relevant documents into the GCP, locking them to the correct version. Please note that Comparison is not currently supported, documents are automatically matched based on the mapping process. Results will include a warning file to inform users of any documents for which a matching relationship could not be found and an unmapped documents file for any documents with no target Content Plan Items (CPIs) or multiple target CPIs found.

How to Enable This Feature

To enable this feature, an Admin will need to perform a one-time configuration:

1. Activate Field: On the Application object, activate the Active Dossier Template field and populate it for all relevant application records. This is required to identify which applications can be used as a reference for baselining.
2. Configure User Action: In the Event lifecycle, replace the old Create Global Content Plan user action with the new Create/Update Global Content Plan actions.
3. Update Templates: On your Content Plan Templates, ensure the Root Content Plan Template field is populated. This helps the system find the correct Active Dossier mappings.
4. Update Content Plan Item Template Layouts: Update layouts for relevant Content Plan Item Template object types to display the Active Dossier Mappings related object section.
5. Load and/or Create Active Dossier Mapping Records: Veeva will provide some Active Dossier Mappings based on standard Active Dossier templates and our recommended GCP Templates. These will be available on the Support Portal for customers to load into their Vaults. Customers can also optionally create Active Dossier Mapping records for Content Plan Item Templates used in Global Content Plans.

Improved Document Set Management

We’re introducing a major upgrade to how you manage document variations in Global Content Plans (GCP). We’re replacing the Document Set picklist with a more powerful, intuitive object data model, making it easier to manage complex document variations across markets within a single GCP.

What’s New

• New Document Set Data Model: Document Set is now a full object, allowing you to track definitions, owners, and planned vs. actual complete dates. A lifecycle is available to communicate the status of individual Document Sets among global teams and can be configured with custom workflows to enforce business processes.
• Centralized Document Set Planning: A new section on the Event page layout lets you create Document Sets and assign them to Activities in one place. You can create them from scratch or from Document Set Template records pre-defined by business users.
• Expanded Assignment in Content Plan: You can now assign Document Sets to Content Plan sections in addition to Content Plan Items. This allows for assignment at a higher level when an entire section belongs to the same Document Set(s) and can prevent empty sections from being dispatched to markets where they are not applicable
• Powerful Content Plan Viewer Tools: We’ve added powerful tools to ease the use of Documents Sets:
  • Bulk Editor and Context-Aware Assignments: In the GCP, use the keyboard and mouse to select multiple Document Set cells. The new floating menu allows you to modify the assignments in bulk through the following actions: Add to Existing (append new values to the ones already present), Update All (override the Document Sets entirely), Remove (take away specific values from the current assignments), or Clear All. To better guide the user, the system now intelligently shows only the Document Set values relevant to the Event you are working on.
  • At-a-Glance Hovercards: Hover over one of the values of a Document Set cell to instantly see additional information, such as its definition and target countries.
  • New and Enhanced Special Filters: To help you focus on what’s relevant, the filtering experience has been upgraded. The previous column filter for Document Set is now a dedicated View by Document Set special filter, which can be applied from the Content Plan Viewer header when viewing a Global Content Plan. Additionally, the existing View by Activity special filter has been enhanced with a more streamlined process, as described in the Release Note for the Content Plan Viewer: View by Activity Filter for GCP feature. While the new View by Document Set special filter is part of this feature, the UI enhancement for the View by Activity filter is available to all customers regardless of its adoption.
• Enforce Document Set Assignment setting: A new Enforce Document Set Assignment Application Setting, ‘Enforce Document Set Assignment’, gives you more precise control over dispatching.
  • When disabled (default): Records in the GCP without an assigned Document Set are dispatched to all valid target submissions.
  • When enabled: Records in the GCP are dispatched only when they have an assigned Document Set that is relevant to the target submission. This enforces explicit assignment for all dispatched content.

Information for Existing Customers

This feature will be available in the 25R3 release via an Application Setting and will become standard for all customers in the 26R3 release.

How the Migration Works

After the 25R3 release, a seamless migration will automatically happen in the background with no downtime. Here’s what Vault handles for you:

• Data Conversion: On release night, your existing picklist data is automatically converted to the new object model. No manual re-entry is needed. If you continue to use the picklist data model after the release, an ongoing migration will continue to keep the object data model up-to-date.
• Updated Saved Views: Any Saved Views using the old Document Set field are automatically updated to include the new Document Set standard column when viewing a Global Content Plan.

Important Considerations for the Migration

Until this feature has been enabled in your environment, the following considerations must be strictly followed to prevent any migration issues:

• Avoid Premature Conflicting Configuration: Do not configure the new Document Set or Document Set Template objects with required fields, validation rules, or other configurations that could conflict with automated record creation. This may cause migration failures.
• Vault Loader Usage: When using Vault Loader to load Activity or Content Plan Item records containing the old picklist field, do not use the No Triggers option. The ongoing migration process relies on triggers, and selecting this option skips the migration for those records.
• Avoid Changing Document Set Picklist Value Names: The migration uses the Document Set picklist value’s name, and not the user-facing label, as a unique identifier over time. If the label is updated after the release, migration triggers recognize this as a new Document Set, resulting in potential duplicates in the migrated Document Set records.
• Avoid Manually Updating Event and Global Content Plan reference fields: The migration relies on an Event referencing a valid Global Content Plan, as determined by the Primary Submission set to “Global Submission”. The Global Submission must also reference the same originating Event. Manual updates to the Global Content Plan field on an Event, the Primary Submission field on Global Content Plan records, or the Event field on Global Submission may result in inconsistencies. Migration may not function as expected in these scenarios. Instead of manually updating fields, we recommend instead using the Create Global Content Plan and Update Global Content Plan actions.
• Avoid Reparenting Content Plan Sections: The migration relies on the entire Global Content Plan structure to reference the same Primary Submission. Reparenting a section (updating the Parent field to reference a Content Plan in a different hierarchy) without also updating the Primary Submission field on the reparented records may result in an inconsistency. Migration may not function as expected in these scenarios. Instead of reparenting, we recommend copying into or dragging and dropping the section instead.

Required Admin Actions

The new features will remain hidden until an Admin takes the following steps:

1. Update your page layouts to make the new features visible to users.
2. Enable the “Improved Document Set Management” Application Setting.
3. Optionally enable the dependent “Enforce Document Set Assignment” Application Setting.
4. Update Permission Sets to grant feature-related permissions.

Trigger to Prevent Reparenting Sections Across GCPs

To help maintain consistent data for the Primary Submission field, and allow for improved Document Set management, Veeva RIM is introducing a new rule for managing Global Content Plan (GCP) hierarchies. The system now specifically prevents GCP sections from being moved or reparented from one GCP into a different GCP.

How It Works

While you can no longer move sections between different GCPs, the flexibility to organize your content plan structure remains.

• Allowed Actions:
  • You can still reparent sections from one part of a hierarchy to another within the same GCP, and between a Submission Content Plan and GCP. For example, you can move a subsection from one top-level section to another inside GCP-001 to restructure your plan.
  • Additionally, users will still be able to copy sections from one GCP to another using Copy Into (Drag and Drop) functionality, which will copy the section and correctly update the Primary Submission field. You can learn more about Copying Into for GCP here.
• Blocked Action: You cannot reparent a section from GCP-001 into the hierarchy of GCP-002.

Content Plan Viewer: View by Activity Filter for GCP

This release enhances the View by Activity special filter within the Global Content Plan (GCP) Viewer.

Key Benefits

• Improved Workflow & Accessibility: Previously to use this filter you had to navigate away from the Global Content Plan, open a specific Activity record, and re-launch the viewer. Now you can apply the View by Activity filter directly from a drop-down menu in the CP Viewer header when viewing a Global Content Plan. This provides a more streamlined process, allowing you to stay within the context of your global plan.
• Available to All Users: This enhancement is automatically enabled for Global Content Plans in all RIM Submissions and Registrations environments, ensuring all users benefit from this improvement immediately.

How it Works

• The fundamental filtering logic remains the same. For a detailed explanation, please refer to the Vault Help documentation.

Important Note

• This enhancement is a standalone improvement and is available immediately, regardless of whether you adopt the new Improved Document Set Management feature.

Content Plan Viewer: Header Styling Update

The Content Plan Viewer grid now has a new appearance to support additional filtering for Global Content Plans. The header row now contains a new gray background, with additional space to support special filter dropdowns for GCPs, such as View by Activity and View as Root. While the styling changes specifically support GCPs, all Content Plans (including SCP and RLCP) will display the new styling:

RIM Registrations, RIM Submissions Archive

RIM Notification Templates: Email Preference Updates

The Challenge

Prior to this feature, some Notification Templates were set to Email Preference: Summary, which can cause a loss of important data:

• For Registrations users: Dynamic token information was lost from the RIM Bulk Create Summary notifications, which prevents them from seeing pertinent results.

• For Submissions Archive users: Important Informational and Warning messages were omitted from the “Import complete” and “Import complete with warnings” notifications.

For tasks like the Source File Path Correction Application Setting, users would not immediately receive information when the job was complete (which is important for successive run scenarios).

Our Solution

In this release, the Email Preference is updated to Every Occurrence for specific Notification Templates in Submissions Archive and Registrations. This ensures pertinent information is delivered via Vault Notification Emails, instead of in the Vault Summary Email Preference format.

The Notifications updated by this feature cannot be set to Email Preference: Summary.

By ensuring a full, detailed notification is sent for every event, this feature ensures users can validate successes, troubleshoot warnings, and proceed with their work without delay.

Affected Notification Templates

The following templates will be updated to be sent with every occurrence:

• SA Source File Path Update Results
• SubmissionsArchive Import Complete
• SubmissionsArchive Import Warning
• RIM Bulk Create Summary
• RIM Bulk Create Summary For Join Records

Enablement

This feature will be enabled automatically as a one-time correction.

RIM Registrations, RIM Submissions, RIM Submissions Archive

Extract Proposed Active Dossier Relationships for Registrations & Product Information Tracking

The 25R1 release introduced new Active Dossier Item Detail (ADID) relationships to provide a more granular view of the Active Dossier based on registration and product information details. For customers adopting this functionality, a new tool is now available to help Active Dossier Admins establish these new relationships—ADID Registration, ADID Product Variant, ADID Manufacturer, and ADID Inactive Ingredient—for existing Active Dossier records. This tool helps populate the relationships for your existing records, making it easier to leverage the new tracking capabilities.

To get started, a new Extract Active Dossier Relationships option is now available under Bulk Actions for the Application object. This action generates a .zip file containing four separate CSV files, which provide a proposed starting set of relationships based on the vault’s current Active Dossier records, document metadata, and Registrations. Admins can review and modify the CSVs to ensure accuracy, then use the Vault Loader to create the new records.

This new workflow significantly streamlines the process of populating the initial set of records for your Active Dossier, making it faster and less tedious than creating the records manually. To enable this feature, Admins must grant the appropriate permissions to the action on to the Application object in the relevant permission set.

RIM Submissions, RIM Submissions Archive

Active Dossier Viewer: Filter by Section

A new Section filter is now available in the Active Dossier Viewer. This feature allows users to easily navigate large dossiers by filtering the view to show only records belonging to specific sections. You can select up to 50 sections to display records from, making it simpler to find the information you need and improving the overall user experience.

When you select a section, all of its parent sections will also be visible up to the Root. For example, if you filter by 3.2.S Drug Substance, its parent sections (3.2 Body of Data, 3 Quality, and the root level) will also be displayed. All of its child sections will also be displayed down to the lowest level that contains Active Dossier records (for example, 3.2.S.1 and 3.2.S.2, and their records).

The Section filter is a secondary filter. It becomes available for use only after you have selected a Root Active Dossier Template (ADT) and at least one other primary filter (transactional or non-transactional).

Prerequisites for Optimal User Experience

For the new filter to be useful, an administrative update is required. The Section filter displays the Name (name__v) field from Active Dossier Templates (ADTs). Since this Name field was originally provided as a technical code (e.g., ADT-000003), Vault Admins need to update it to match the more descriptive Display Name (display_name__v) (e.g., 3.2.S Drug Substance).

To assist with this update, a Loader Sheet will be available with this release. Contact your Managed Services team or Support for the template and instructions.

Active Dossier Support for Clinical Study, Nonclinical Study & Indication

This release significantly enhances Active Dossier by introducing support for Clinical Studies, Nonclinical Studies, and Indications.

New Standard Templates for CTD

This release introduces new standard templates for Module 4 (Nonclinical) and Module 5 (Clinical) sections of the existing CTD hierarchies (Marketing and Investigational), as well as an indication-driven section in Module 2.

These templates are built using new tokens for ${clinical_study__v}, ${nonclinical_study__v}, and ${indication__v} to automatically create the correct structure for each study. This dynamic behavior is consistent with how existing tokens like ${product__v} work, ensuring a predictable user experience. Additionally, new Study Type and Study Subtype fields help the system identify the precise template section for each study-level record.

Traceability for Published RLCP Documents

This feature includes additional support for reports published using a Report Level Content Plan (RLCP). When a published RLCP document is included in a Submission or Global Content Plan, Active Dossier now tracks both the final published report and the original source documents it was created from. The system traverses the published RLCP document’s source references to determine the source documents of each published report document.

Viewer & Editor Experience

To support management of the new data the Active Dossier Viewer and Editor have been updated:

• New Global Filters: You can filter your dossier view by selecting one or more Clinical Studies, Nonclinical Studies, or Indications. These filters can be saved in custom views.
• Expanded ‘By relationships’ Filter: The By relationships secondary filter has been expanded to now include Clinical Study, Nonclinical Study, and Indication relationships. This filter applies the same powerful logic it already uses for Product, Active Substance, and Inactive Ingredient relationships, gathering all Active Dossier records that share relationships with the item selected in the global filter (Event, Regulatory Objective, or Submission). This provides a complete view of related content from across the system.
• Product Family Filtering: Filtering by Product Family has been enhanced in two key ways for a more complete overview.
  • The ‘By Product & Active Substance’ secondary filter has been renamed to ‘By Product Family relationships’ and expanded to include all associated Clinical and Nonclinical Study records.
  • The ‘By Application’ secondary filter has been similarly improved. When you use this filter, the view will now display not only the Applications linked to the Product Family, but also the specific Clinical and Nonclinical Studies associated with each of those Applications.
• New Columns: The Viewer includes columns for Clinical Study, Nonclinical Study, Indication, and Published Report Document.
• Create and Edit Records in the Editor: The Active Dossier Editor fully supports study and indication-related records, allowing you to edit the Clinical Study, Nonclinical Study, and Indication fields directly, consistent with how other sections and fields are managed.
• Enhanced Validation in the Editor: The Active Dossier Editor now includes new validation rules to ensure data integrity, aligning it with the validations that already exist in the Active Dossier Loader. For example, the system prevents users from populating mutually exclusive fields (like Product and Clinical Study) on the same record.

For Administrators: Enablement & Setup

This is an auto-on feature that requires additional setup to become fully operational. The new standard templates are delivered as inactive.

To enable this feature, you will need to:

• Activate the New Templates: Activate the relevant new Active Dossier Templates.
• Map Document Types to RIM Reference Models or Active Dossier Templates: Map your organization’s existing document types to the new RIM Reference Models or directly into the Active Dossier Templates.
• Configure RLCP Tracking: To track published RLCP output, the Published by RLCP field must be configured on the relevant document types (we recommend adding it to the Base document type). This document field is what Active Dossier uses to determine if a document is a published report document.
  • Note: We recommend temporarily making the Published by RLCP field editable to update existing published report documents since it will not be retroactively set on documents published before the field was configured.
• Assess Study Types and Subtypes: After activating the templates, please review the Clinical Study Type/Subtype and Nonclinical Study Type/Subtype fields. These fields may be blank if your environment is missing the corresponding Controlled Vocabulary records. Before you can populate these fields on the templates, you must first create the necessary Controlled Vocabulary records with the standard UUID.

Additionally, the Active Dossier Loader has been updated to support bulk creation and migration of records using all the new fields introduced in this feature.

Active Dossier Hovercard Updates

This release introduces usability improvements to hovercards within the Active Dossier Viewer, integrating recent features and streamlining the user interface.

Key Updates

• Country Hovercard: Now incorporates data from the Dates & Comments Tracking feature (25R2). The hovercard surfaces the most relevant date in the header, comments, and an updated Approval Type display.

• Registrations & Product Information Hovercards: To reduce visual noise, the hovercards for Registrations, Product Variants, Manufacturers, and Inactive Ingredients in the Item Detail layout no longer display column filters or a search bar. A new pop-out icon allows users to open a full view in a new window for detailed searching and filtering.

This is a user interface update that will be automatically enabled for all users. No configuration is required.

RIM Submissions Archive

Bosnia and Herzegovina eCTD 3.2 Archive & Viewing (BA v3.1)

Submissions Archive now supports importing, viewing, and exporting of submissions in compliance with the Bosnia Health Agency ALMBiH v3.1 DTD and regional specification v1.0.

This new functionality allows archive management and viewing of submissions according to the local regulatory requirements for BA eCTD specification v1.0

Tunisia eCTD 3.2 Archive & Viewing (TN v1.1)

With this release, Submissions Archive supports importing, viewing, and exporting of Tunisia submissions using the ANMPS regional specification v1.1.

Hide Cumulative View for Japan eCTD 3.2 Submissions

To provide a cleaner, more intuitive experience in the Submissions Archive Viewer, the Cumulative View action is no longer shown for Japan eCTD 3.2 submissions. This view is not compatible with the JP XSD 1.0 Cumulative XML format (eCTD 3.2). The Historical Lifecycle of Document user action remains supported in Japan eCTD 3.2 submissions.

The previous availability of the Cumulative View in the Action menu was an invalid action for Japan eCTD 3.2. To prevent user confusion when trying to launch this nonfunctional view, the user action has been automatically removed from the Archive Viewer actions.

eCTD 4.0 Viewing: Document Reuse & Document Title Display

For eCTD 4.0 applications, the Submissions Archive Viewer now accurately displays the most recent Document Titles that have been updated within an application via the eCTD 4.0 concept of Document Reuse. Submissions Archive Viewer will display Document Title updates per the handling improvements introduced by the new eCTD Metadata Updates: Document Reuse Optimization feature.

Impact

This feature automatically addresses a data display inconsistency between Submissions Archive Viewer and the eCTD Metadata Updates export CSV file, when Document Reuse includes an updated Document Title across applications.

Submissions Archive Harmonization for eCTD 4.0 Keywords

The Submissions Archive Harmonization Job now automatically processes and displays ICH eCTD 4.0 submissions accurately, even if they were not imported in sequential order. This includes the correct display of Sender Defined eCTD Keywords even when sequences are imported out of order.

Additionally, users will receive Vault Notifications and emails if any Sender Defined eCTD Keywords or Sender Defined Keyword Codes are missing from imported submissions even after the Job and asynchronous actions are completed. Code, Code System, and Sequence ID of the missing Sender Defined Keyword.

Considerations

If Suspend operations are included in out-of-sequence submission imports, the structure and Name column may still not display correctly. The Suspend operation imports will be addressed in a future release.

eCTD Metadata Updates: Document Reuse Optimization

Submissions Archive can now recognize documents by their Document UUID across all reuse cases. Previously, this UUID recognition was only available for documents reused within the same Application. As cross-application reuse is a critical component of eCTD 4.0, this change allows for document reuse cases to be fully resolved in the exported CSV file.

With this enhancement, users will also see improved handling of Document Titles for all documents with the same Document UUID value, regardless if the document appears in the same application or in submissions for a different application.

Impact

For customers who are publishing, importing, or Viewing eCTD 4.0 submissions, Submissions Archive will automatically perform the following actions:

• Enable Cross-Application Document Reuse: The system will find a document by its Document UUID, even when the document has been reused in different Applications.
• Enhanced eCTD Metadata Updates Export: The eCTD Metadata Updates output file will now include an Applications column to aid users in identifying their document reuse scenarios. Export will include documents reused within the same submission, reused in different submissions in the same application, and reused in submissions in a different application.

Import Notification for Missing Primary Filename

Submissions Archive now provides a Warning message when an imported dossier contains one or more files that lack a primary filename (e.g., the filename is only the extension .docx). Vault uses the file’s extension as the Document Name for the Submissions Archive Document during import, and the ‘Import complete with warnings’ notification lists each Document Name for user review.

• With this enhancement, Vault uses the file extension as the Document Name for these documents in Submissions Archive (if a new document is being created).
• The Submissions Archive import complete with warnings Notification, sent to the import initiating user, and Import Results CSV file attached to the Submission record lists each Document Name handled in this way in the Warning section of the notification
• The Notification Text reads as follows:

Representative File Name Examples

This enhancement ensures a complete and accurate archive that exactly matches what a Health Authority accepted, removing the need to edit filenames before importing.

File Name Update for Import Results Attachment

In this release, the Submissions Archive Import Results CSV file name is updated to append a system-generated unique identifier at the end of the file name. This update only affects the system-generated file name of the CSV, not the structure or content of the file. This change is being made to support back-end file name uniqueness and will not impact imports or Viewer user experience.

Considerations

Each time the Reimport action is executed, the system will attach a new Submissions Archive Import Results CSV file with its own unique file name.

An example of the file name structure can be found below:

Safety

For the latest central dictionary updates for your Safety Vault, see Safety Central Dictionary Updates.

Several features listed in the Veeva Connections section also affect the Safety application family.

In addition to the below release notes, the Safety and SafetyDocs Veeva Connect communities offer general release communications, release highlights, and key feature demos.

Safety

Document Intake Highlighter: Display Annotations in View Mode

With this release, Veeva Safety improves the Document Intake Highlighter panel by showing highlighted terms in View mode. Highlighted terms were previously only visible in Annotate mode, where annotation info cards occupied screen space. This enhancement streamlines document review, saves time, and provides a cleaner viewing experience, helping teams process documents faster and with fewer visual distractions.

Learn More

• User Help: Document Intake Highlighter

Multi-Case CSV Data Import: Low-Touch Automation Efficiency

With this release Veeva Safety makes it easier and faster to import multi-Case tabular data. By supporting more objects, fields, and limits across both tabular data imports and the JSON API, the intake process is now streamlined and far less manual. This ensures quicker triage, more accurate data entry, and reduced risk of errors, saving time and improving overall efficiency.

Learn More

• Enablement: Enable Multi-Case Tabular Data Import
• Admin Help: Manage Multi-Case Tabular Data Import
• User Help: Import an Inbox Item

Enhanced Potential Matches Page for Duplicate Detection

With this release, Veeva Safety introduces a new Potential Matches page. The enhanced page helps users quickly identify the most relevant potential matches with intuitive icons and logically organized fields. This feature is Auto-on in Vaults configured for Duplicate Search Potential Matches Page. Other Vaults require configuration.

Learn More

• Enablement: Safety Application Settings & Configuration Options
• User Help: Promote to Case

Inbox Item to Case Compare Page: Improved Matching & Highlights

With this release, Veeva Safety improves the matching logic on the Inbox Item to Case Compare page and adds visual indicators (including an unmatched indicator) that highlight case records that could be potential matches to new incoming records. This enhancement helps users quickly identify records during follow-up case processing that require manual review when incoming data conflicts with existing records. In addition, Vault now considers Qualification field values on Case Contacts when identifying matches.

Learn More

• User Help: Perform Inbox Item to Case Compare

Inbox Item to Case Compare Page: Option to Ignore All from Specific Origins

With this release, Veeva Safety introduces an Ignore All option on the Inbox Item to Case Compare page. Admins can define the specific sender origins for which this option appears on the page for user selection. This enhancement streamlines the selection of verified new information and reduces clicks, especially for Inbox Items from sources with lower data quality.

Learn More

• Enablement: Safety Application Settings & Configuration Options
• User Help: Perform Inbox Item to Case Compare

Imported Follow Up Information Cases for Migration

With this release, Veeva Safety adds the Imported Follow Up Information object type to the Case object. This new data model supports the migration of follow up date information into Veeva Safety from other safety systems. 

Learn More

• User Help: Migrate External Cases

Process Completion Date Population for Inactive Cases

With this release, when a Case moves into the Inactive lifecycle state, Vault populates the Process Completion Date with the current date and time. This feature supports more accurate monitoring of completed Case volume and improves Case Volume Metric data visualizations.

Learn More

• User Help: View Case Volume Metrics

Gestation Age at Outcome Control

With this release, Veeva Safety adds a new Gestation Age at Outcome control field to the Case object. By default, this control field has Atomic Security set to Edit. If your organization considers this Personally Identifiable Information (PII), adjust the Atomic Security for this field accordingly.

Learn More

• Enablement: Enable Pregnancy-Related Case Fields
• User Help: Process Pregnancy, Child Information, and Parent Information Cases

Unknown Formulation Product Selection

With this release, Veeva Safety streamlines adverse event case processing by adding support for Products with unknown formulations. Vault creates an unknown formulation Product on each newly created Product Family, as well as allowing Admins to manually create unknown formulation Products when reported product details are not specific. This feature prevents manual data workarounds and enhances data consistency by ensuring a standardized approach to handling cases with limited product information.

Learn More

• Enablement: Enable Unknown Formulation Product Selection
• Admin Help: Manage Products

Combination Product Type Identification

With this release, Veeva Safety adds the Combination Product Type field to the Product object, which clearly identifies when Combination Products include drugs, devices, or both. Vault populates the field based on the related Product Constituents and their Product Registrations.

Learn More

• Enablement: Enable Combination Products
• Admin Help: Manage Combination Products

Auto-Code CAS Numbers for Case External Products

With this release, Veeva Safety automatically identifies and maps Chemical Abstracts Service (CAS) numbers to Case Product Substances created when a user codes an External Product using the WHODrug Search browser. As CAS numbers are required for submissions to the Korean Ministry of Food and Drug Safety (MFDS) and optional under ICH E2B(R3) guidelines, this enhancement streamlines regulatory compliance by reducing the manual effort necessary to produce accurate substance-level information.

Learn More

• Admin Help: Manage the WHODrug Dictionary
• User Help: Code WHODrug Products

Exclude Concomitant Products from Auto-Coding

With this release, Admins can exclude concomitant products from auto-coding against the Product library during structured intake, including E2B, JSON, and CSV files. When promoting Inbox Items to Cases, Vault classifies concomitant products as External Products. Previously, Vault attempted to match concomitant products to Products in the Product library. This enhancement addresses a common challenge where concomitant medicinal products are classified as company products, resulting in the need for manual correction.

Learn More

• Enablement: Enable Company Product Match Verification
• User Help: Inbox Item Study and Product Matching

Auto-Update Related Case Identifiers in Case Relationships

With this release, following changes to the related Case on a Case Relationship record Vault can automatically update the Related Case Identifier value with either the UID or Worldwide UID of the new related Case. This eliminates the need to manually update this information, which is particularly helpful in scenarios involving literature or legal cases where multiple related Cases are linked. This feature reduces manual data entry, minimizes errors, and improves the accuracy and consistency of linked case data, ultimately enhancing operational efficiency and user productivity.

Learn More

• Enablement: Enable Auto-Update Related Case Identifiers in Case Relationships
• User Help: Case Field Reference

Updated SUSAR Tagging Behavior

With this release, Vault tags Cases as SUSAR only when the report type is classified as Study. This update resolves situations where Vault tagged Cases with a report type of Spontaneous as a SUSAR if they referenced a Study with unspecified products. In such cases, Vault previously allowed SUSAR tagging on Cases or Case Assessments despite the report type not meeting the criteria. This ensures SUSAR tagging is correctly restricted to Study reports, ensuring more accurate classification and compliance with regulatory standards.

Learn More

• User Help: How Vault Assigns Case SUSAR and SAE Tags

Tag Only Clinical Trial Study Cases as SUSAR

With this release, Admins can configure their Vault to tag Case Assessments as SUSAR only when they are associated with a clinical trial study. Previously, Vault tagged SUSARs on any Case with the Report Type set to Study, regardless of the study type. By improving tagging accuracy, reducing the risk of misclassification, and ensuring compliance with regulatory definitions, this enhancement supports higher-quality data and more reliable safety reporting.

Learn More

• Enablement: Enable Case Level Relatedness and Automatic SUSAR/SAE Tagging
• User Help: How Vault Assigns Case SUSAR and SAE Tags

Assessment Dechallenge Calculation

With this release, Veeva Safety calculates Dechallenge values on Case Assessments based on the Action Taken on Case Products and the Outcome on Case Adverse Events. This enhancement includes the flexibility for users to manually override Vault-generated values if needed. By automating dechallenge evaluations, this feature reduces manual data entry, improves data consistency, and supports faster, more accurate case evaluations. It also minimizes the need for custom logic or configuration, lowering administrative overhead and enabling more efficient regulatory reporting.

Although this feature is Auto-on, some components may require additional configuration.

Learn More

• Enablement: Enable Assessment Dechallenge Calculation
• User Help: How Vault Calculates Dechallenge

Enhanced Product Browser for Studies with Unspecified Products

With this release, in Vaults with Faster Case Product Selection enabled, the Product Browser displays for imported Inbox Items that have a Study with Unspecified Products.

Korea Drug Browser Support for Case Drug History

With this release, Veeva Safety includes Korea Drug Browser for Case Drug Histories, enabling users to search, browse, and code Korean drugs. This feature supports lookup and coding of Ministry of Food and Drug Safety (MFDS) Medicinal Product Identifiers for externally registered products in Korea, helping ensure regulatory compliance, improve data accuracy, and streamline case processing for Korean market submissions.

Learn More

• Enablement: Enable the Korea Drug Dictionary
• User Help: Code Korea Drug Dictionary Products

Non-Current Tag for Japanese MedDRA Coding

With this release, when a non-current Japanese term is coded with MedDRA, Veeva Safety displays a NON-CURRENT tag, along with displaying the coded Japanese term as “-“. The English term displays as expected, without any tag. Non-current Japanese MedDRA terms are typical for Lowest Level Terms (LLTs) where the translation of multiple English terms result in a duplicate Japanese term.

Learn More

• User Help: Code MedDRA Terms

Korean Drug Substance Coding

With this release, Veeva Safety codes Korean domestic Case Product Substances and Korean Localized Case Product Substances with the Chemical Abstracts Service (CAS) Number and Korea Ministry of Food and Drug Services (MFDS) Substance IDs for use in submissions to MFDS. This feature supports compliance with MFDS regulations.

Although this feature is Auto-on, some components may require additional configuration.

Learn More

• Enablement: Enable the Korea Drug Dictionary
• User Help: Code Korea Drug Dictionary Products

Extend Upgrade to Latest Action to Update MedDRA SMQs

With this release, Vault includes the latest Standard MedDRA Queries (SMQs) when you run the Upgrade to Latest action to update the central MedDRA Dictionary, replacing the previous method where SMQs had to be upgraded separately through manual ZIP file uploads. This enhancement streamlines the MedDRA upgrade process, saving time and reducing effort.

Although this feature is Auto-on, some components may require additional configuration.

Learn More

• Enablement: Enable Standardized and Custom MedDRA Queries
• Admin Help: Manage the MedDRA Dictionary
• User Help: Use MedDRA Queries

Manage Blind Protection for Case Narratives

With this release, Admins can manage blind protection for narrative documents using the Turn off Blind Protection on Narrative setting without first having to enable the Enable Isolation of Blinded Product Information setting. When enabled, Vault sets the Blind Protection field on generated narrative documents to Off. The removal of this dependency gives Admins more flexibility and control.

Learn More

• Enablement:
  • Enable Rules Based Narrative Generation
  • Enable Narrative Templates for Report Types and Studies
• User Help: Generate a Case Narrative

Rules Based Narratives: 25R3 Updates

With this release, the Rules Based Narrative Generation feature is updated to further streamline and improve efficiency during case processing, including:

• List Enhancements: The VS_repeat function now supports the list and LIST operators for any Case child object. For example, narrative outputs generate a grouped statement with ‘‘and’’ separating the rendered values. In addition, Vault separates outputs with three or more grouped statements with commas.
• Standard Narrative Outlines: Veeva now provides standard Narrative Outlines. Previously, Admins had to use Vault Loader to import sample Narrative Outlines to their Vaults. 
• Bulk Unblind: During bulk unblind follow-up creation, if a user enters text on the Narrative Text field Vault generates a Case Follow-up Statement with the contents of the field value.

Learn More

• Enablement: Enable Rules Based Narrative Generation
• Admin Help: Configure Rules Based Narratives
• User Help: Generate a Case Narrative

PMDA: Clear Non-Reportable Case Product Registrations

With this release, when processing PMDA-reportable Cases, the Retrieve Reportable Case Product Registrations action on Localized Cases now removes non-reportable Case Product Registrations if no PMDA-reportable registration exists for the Product. Previously, these non-reportable registrations remained on the Case.

Learn More

• User Help: Complete Intake and Process Cases for the PMDA

PMDA: Clear Case Product Registrations for Inactive Products

With this release, when processing PMDA-reportable Cases, the Retrieve Reportable Case Product Registrations action on Localized Cases now clears out non-reportable Case Product Registrations when the related Product Registration has been inactivated.

Learn More

• User Help: Complete Intake and Process Cases for the PMDA

PMDA Medical Device and Regenerative Medicine Reporting: Data Model

With this release, Veeva Safety introduces the data model to support capturing and managing medical device and regenerative medicine products information on domestic Cases and Localized Cases for Japan. This feature lays the foundation for future XML generation and electronic reporting of these product types to the PMDA.

Although this feature is Auto-on, some components may require additional configuration.

Learn More

• Enablement: Enable PMDA Medical Device and Regenerative Medicine Reporting: Data Model
• Admin Help: Set Up the Localized Business Admin Library for Japan
• User Help: PMDA Case Field Reference

CIOMS I (Chinese) Form Generation

Veeva Safety now supports the generation of CIOMS I forms localized for submission to the National Health Commission (NHC) of China and distribution to partners. When a transmission includes a CIOMS I (Chinese) form, Vault maps data from the corresponding Localized Case. If localized data is unavailable, Vault populates the form using global Case data to ensure completeness and consistency. This capability enhances global regulatory compliance by automating a region-specific reporting requirement.

Learn More

• User Help: CIOMS I (Chinese) Generation Data Mapping

FDA MedWatch 3500A (August 2024 Version): Compounded Product Update

With this release, Veeva Safety adds support for the G.4 Compounded Product field on the FDA MedWatch 3500A (August 2024 version) form. Across all Case Products in sections C and D, if any component of a Product has an FDA Product Registration with a Compounding Type value, Vault now selects the G.4 checkbox on the form.

Learn More

• Admin Help:
  • Manage Products
  • Manage Combination Products
• User Help: FDA MedWatch 3500A (August 2024 Version) Generation Mapping

FDA eMDR Generation & Manufacturing Report Number Automation

With this release, Veeva Safety supports the generation and submission of XML files for electronic medical device reporting (eMDR) to the FDA and for distribution to partners. This feature introduces the necessary objects and fields for reporting adverse events involving medical devices to the FDA. In addition, Vault now supports tracking and exporting manufacturing sites and manufacturing report numbers to the FDA eMDR XML and the August 2024 version of the FDA MedWatch 3500A form. This feature ensures compliant generation and transmission of reports to the FDA.

Learn More

• Enablement: Enable FDA eMDR Generation & Manufacturing Report Number Automation
• Admin Help: Manage Organizations
• User Help:
  • FDA eMDR Generation Data Mapping
  • FDA MedWatch 3500A (August 2024 Version) Generation Mapping

Patient Content Protection: Mask PII (EU Guidance)

With this release, Vault introduces support for masking EMA E2B(R3) files based on the latest EU GVP Module VI Addendum. This includes two new options on the Mask PII reporting rule parameter.

Learn More

• Enablement: Enable Masked Content Distributions
• User Help:
  • Reporting Rule Parameter Reference
  • Generate Masked Safety Reports

Enablement Update: Convert EMA E2B(R3) Validations to Vault Expressions

In 25R2, Veeva Safety introduced EMA E2B(R3) validations that used Vault Expressions instead of JSON. In 25R2, this feature required support configuration. With this release, the feature is now auto-on.

Convert FDA VAERS E2B(R3) Validations to Vault Expressions

In this release, the validations that Veeva Safety performs for FDA VAERS E2B(R3) Case and Submission data now use Vault Expressions instead of JSON. This improves the maintainability and readability of FDA VAERS E2B(R3) business rule validations. Additionally, Safety has updated the FDA VAERS E2B(R3) validations to ensure full alignment with the latest agency business rules.

Validation Criteria: Added First and Last Admin Date Validations

With this release, Vault introduces additional ICH validation criteria for G.k.4.r.4 and G.k.4.r.5 to check that the First Admin Date is not earlier than the Last Admin Date. This ensures that validations remain fully aligned with the latest agency business rules.

Validation Criteria: Updated Marketing Definitions for FDA E2B(R3) Validations

In this release, the validations that Veeva Safety performs for FDA E2B(R3) Case and Submission data have been updated to align with the following marketing definitions:

• Pre-Market: CBER Study (fda_cber_study__v), CDER Study (fda_cder_study__v), or CDER IND Exempt (fda_cder_ind_exempt__v)
• Post-Market: CBER (fda_cber__v), CDER (fda_cder__v), or CBER VAERS (fda_cber_vaers__v)

In addition, the following validation criteria now evaluate at the Submission level only:

• FDA.C.5.4-1
• FDA.D.9.1
• FDA.G.K.1-1
• FDA.G.k.12.r.3.r
• FDA.G.K.9.i.2.r.3-1

Validation Criteria: Add Reason Omitted Requirements for FDA.D.11 & FDA.D.12

With this release, the FDA.D.11-RO validation criteria now also requires that if Race is blank, Race (Reason Omitted) is required.

Similarly, the FDA.D.12-RO validation criteria now also requires that if Patient Ethnicity is blank, Patient Ethnicity (Reason Omitted) is required.

This update ensures compliance with regulatory reporting requirements by enforcing the appropriate capture of omission reasons when race or ethnicity data is not provided.

Validation Criteria: Additional FDA.D.9.1 Nullflavors

In line with FDA business rules, the FDA E2B(R3) validation criteria for FDA.D.9.1 now includes the following null flavors:

• MSK
• ASKU
• NASK

Validation Criteria: Exclude Treatment Drug Role from FDA.G.K.1-2,3,4

In line with FDA business rules, the following FDA E2B(R3) validation criteria now exclude Treatment Drug Role:

• FDA.G.K.1-2
• FDA.G.K.1-3
• FDA.G.K.1-4

This ensures full alignment with the latest agency requirements.

Validation Criteria: Update ICH G.k.2.2 and H.1 for NMPA Submissions

With this release, Veeva Safety updates the validation criteria for NMPA E2B(R3) Submissions. As a result, Vault does not evaluate the ICH.G.k.2.2 and ICH.H.1 validation criteria if there are no Localized Cases for the NMPA.

Validation Criteria: MFDS.G.k.9.i.2.r.3.KR.1-1,2 Check Global Case Data

With this release, Veeva Safety updates the MFDS validation criteria for WHO-UMC (MFDS.G.k.9.i.2.r.3.KR.1-1 and MFDS.G.k.9.i.2.r.3.KR.1-2) to also evaluate global Case data. Previously, these validations evaluated Localized Case data only. This update ensures full alignment with the latest agency business rules.

MFDS E2B(R3): G.k.9.i.2.r.3.KR.1 Export Update

This release updates how Vault populates the G.k.9.i.2.r.3.KR.1 WHO-UMC Result of Assessment data element when generating MFDS E2B(R3) files for domestic Cases that are not associated with a study. If the Localized Case Assessment Result does not contain a Localized Assessment Result value, Vault exports a value based on the Assessment Result on the Case Assessment Result.

Learn More

• User Help: E2B Generation: MFDS E2B(R3) Mapping

EU MIR 7.3.1: PDF & XML Generation

With this release, Veeva Safety supports the generation and submission of the European Commission’s Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD), Version 7.3.1, replacing Version 7.2.1. In addition, Vault can now export this form in both PDF and XML format, instead of PDF only. By supporting the updated version of the EU MIR form, released in July 2025 and mandatory from November 2025, this feature ensures compliant generation and transmission to the European Database on Medical Devices (EUDAMED).

Although this feature is Auto-on, some components may require additional configuration.

Learn More

• Enablement: Enable European Union Manufacturer Incident Report (EU MIR) PDF Generation
• User Help: EU MIR Generation Data Mapping

NMPA E2B(R3): Data Model, Mapping, Validation, & Syncing Updates

With this release, Veeva Safety updates the data model, data mapping, validation, and Localized Case snapshotting for NMPA E2B(R3) generation to align with agency business rules. The improvements include:

• NMPA E2B(R3) data mapping: Updates to sections C, D, E, F, and G 
• Localized Case snapshotting: Field snapshots for Localized Cases now occur in the following instances:
  • During the one-time sync from a global Case to a foreign Localized Case
  • Upon foreign Localized Case creation
  • Upon domestic Localized Case creation
  • Following ad hoc changes to a domestic Localized Case
  • Following merge to an in-flight Case or creation of a follow-up Case from the Inbox Item to Case Compare page for a domestic Localized Case
• Validation: Updates Validation Criteria to support compliant Transmission documents

Although this feature is Auto-on, some components may require additional configuration.

Learn More

• Enablement: Enable NMPA E2B(R3)
• User Help:
  • E2B Generation: NMPA E2B(R3) Mapping
  • Localized Case Field Reference

Blinded Cases Rule Evaluation for Agencies

With this release, the Veeva Safety Reporting Rule Engine supports the ability to determine agency reportability for blinded clinical trial Cases. This feature helps satisfy regulatory requirements for health authorities where blinded Serious Adverse Event reporting is required.

Learn More

• Enablement: Enable Blinded Cases Rule Evaluation for Agencies
• Admin Help: Manage Organizations
• User Help: Reporting Rules Product Selection

Allow Case Data Expressions to Reference Inbound Transmissions

With this release, Veeva Safety extends the Case Data - Expression parameter to allow references to Inbound Transmissions for Safety Reporting Rules and Validation Criteria. This enhancement provides additional reporting flexibility, allowing for tailored evaluation criteria without the need for custom SDK development.

Learn More

• Admin Help: Configure Custom Validation Criteria
• User Help: Reporting Rule Parameter Reference

Sender-Based Inbound Validation Compatibility

With this release, Admins can now enable Sender-Based Inbound Validation for inbound sources that also use Automated Case Promotion or Local Intake Auto-Translation for E2B transmissions received via the AS2 Gateway or Vault API.

Learn More

• Enablement:
  • Enable Sender-Based Inbound Validations
  • Enable Automated Case Promotion
  • Enable the Auto-Translation Framework for Localized Intake and Case Submissions
• Admin Help: Manage Transmission Profiles

AS2 Connection / Transmission Profiles Enhancements

With this release, when creating a Transmission Profile of the AS2 Gateway type, Vault no longer creates a corresponding Gateway Profile. In addition, customers can create an unlimited number of Transmission Profiles for use with AS2 Connections.

Learn More

• Admin: Configure Custom AS2 Connections

Product Alias: Data Model

With this release, the Alias Type picklist is added to the Product Alias object to support pre-defined Product selection.

Base64 Encoding for Transmission Files

For partners and agencies that require it, Veeva Safety now supports the option of encoding transmission files using Base64 for ICSR Transmissions sent by AS2 Gateway. This update ensures full alignment with the latest agency business rules.

Windows-style Line Endings for Transmission Files

By default, Veeva Safety uses Unix-style line endings in transmission files for ICSR Transmissions sent by AS2 Gateway. For partners and agencies that require it, Veeva Safety now supports the option of using Windows-style line endings in transmission files instead of Unix-style line endings. This update ensures full alignment with the latest agency business rules.

MDN/ACK Transmission Message Attachment Update

With this release, for partners and agencies that send their AS2 Gateway ACK/MDN using UTF-16, Vault no longer creates attachments on the Transmission Message for the ACK or MDN. Instead, Vault uses the default method of creating the MDN and ACK Transmission Message by populating the content of the XML file in the Body of the Transmission Message.

Safety Workbench

Navigate to a Safety Object from Workbench

This feature allows users to directly access related Safety object records, such as Cases or Products, from Workbench Dashboards and Workbench Report Excel outputs. Users can now select a link to view or modify detailed information within Veeva Safety. This creates a seamless workflow and eliminates the need to search for records in separate tabs.

Learn More

• User Help:
  • Set Up the Workbench Report Layout
  • Manage Workbench Dashboards

Filter a Workbench Report Using Starts With and Contains Operators

With this release, Veeva Safety Workbench allows users to filter reports using the starts with and contains operators for text fields. This enhances data search flexibility, enabling users to easily find specific information, such as lot numbers, directly within Workbench Reports.

Learn More

• User Help: Use Workbench Report Filters

Filter a Workbench Report by Signal Case Series

This feature allows users to filter Workbench Reports using Signal Case Series, constraining results in the report output to only the Cases within that series. This enhances targeted reporting and analysis by leveraging existing Signal data for more precise insights in Veeva Safety Workbench.

Learn More

• User Help:
  • Manage Workbench Reports
  • Create Statistical Data

Workbench Dashboard Usability Enhancements

With this release, Veeva Safety Workbench enhances dashboards by allowing users to view thousands of rows of data with new pagination features and automatic column resizing. This enables more comprehensive data analysis and increases the previous 500-row limit on table visualizations. Users can also sort data and see a live count of records for improved usability and analysis. This feature enhances data exploration and analysis within Veeva Safety Workbench

Learn More

• User Help: Manage Workbench Dashboards

Export a Workbench Dashboard Component as CSV

This feature allows users to export data directly from a Workbench Dashboard Component to a CSV file. This enhances data analysis flexibility, enabling users to easily extract filtered dashboard data for further use in documents or spreadsheets.

Learn More

• User Help: Manage Workbench Dashboards

Generate Reports from Workbench Dashboard Components

This feature allows users to generate and run a new Workbench Report directly from a Workbench Dashboard Component. Vault applies the component’s layout and view as well as dashboard filters to create the report, and then notifies the user after successfully running the report. This feature streamlines data analysis by empowering users to perform additional actions on dashboard data.

Learn More

• User Help: Manage Workbench Dashboards

Workbench DSUR & PBRER Case Completed Filter

This feature allows users to filter Workbench DSUR and PBRER aggregate reports to include or exclude open cases. This feature enhances efficiency during the reporting period by allowing users to generate preliminary drafts with an estimate of the total case count for analysis and the final, submittable version of the report.

Learn More

• Admin Help: Manage Derived Fields
• User Help:
  • Create Workbench DSUR Aggregate Reports
  • Create Workbench PBRER Aggregate Reports

Supplemental Reports for Workbench PADER Aggregate

With this release, users can generate the following new supplemental PADER aggregate reports in Veeva Safety Workbench:

• 15-Day Report Line Listing Summary
• Case Series
• List of Death Cases
• List of Nullified Cases
• Non-Expedited Line Listing Summary

These additional reports enable customers to conduct more in-depth analysis for their PADER submissions, enhancing report preparation and data insights.

Dynamic Views for Ad-Hoc Report Customization

With this release, Veeva Safety Workbench introduces Dynamic Views, which allows users to select from a list of commonly used Safety fields for custom reporting. This feature eliminates the need for numerous, all-encompassing views that can be inefficient to run and offers a more flexible, high-performing solution for ad-hoc analysis and reporting.

Learn More

• Admin Help: Configure Dynamic Safety Views

Clearer Error Handling for Workbench View Configuration Errors

In this release, Safety Workbench improves error handling when Admins configure Workbench Views. This will make it easier for Admins to build custom Workbench Views.

SQL Editor Enhancements

Veeva Safety Workbench introduces improved UI for the SQL Editor section on safety views, which includes syntax highlighting and line numbers. Keyboard shortcuts are also now available for the SQL editor. This feature enhances the experience of writing and reviewing custom SQL views, boosting user efficiency for advanced reporting.

Learn More

• Enablement: Enable SQL Editor Enhancements
• Admin Help: Configure Safety Views in Safety Workbench
• User Help: Safety Workbench Keyboard Shortcuts

Clearer Error Handling for SQL

This feature allows users configuring safety views to see SQL error messages when saving or previewing a view. Users can also download a log file to troubleshoot more complex queries. This feature provides essential troubleshooting tools for custom SQL development, reducing reliance on Veeva Support and enabling faster issue resolution for reporting teams.

Although this feature is Auto-on, some components require additional configuration.

Learn More

• Admin Help: Troubleshoot Workbench

Safety Signal

Listedness from Core Datasheets

With this feature, Veeva Safety Signal provides an option to determine listedness based on Company Core Datasheets (CCDS) from all Products within a Product Family, instead of looking at the Case Assessment field listedness from core Datasheets. Admins can configure safety views to support this change and determine whether an adverse event is actively listed during the signal review period. This feature provides a more comprehensive and up-to-date listedness.

Learn More

• Admin Help: Configure Safety Views in Safety Signal
• User Help: Scheduled Signal Calculations & Alerts

Successful Record Creation During Scheduled Calculations

During scheduled Signal Calculation runs, if some parts of the data creation fail, Vault now retains the records that were successfully created, such as Product-Event Combinations, PEC Periods, and Statistical Data, to allow you to access successfully processed information.

Learn More

• User Help: Scheduled Signal Calculations & Alerts

Calculations and Statistical Data Creation for FAERS

With this release, Veeva Safety Signal introduces the ability to run calculations on quarterly FDA Adverse Event Reporting System (FAERS) data, for example, Empirical Bayes Geometric Mean (EBGM) and Case counts. This feature also allows users to create Statistical Data to store calculation results for FAERS. This feature enhances signal detection by providing a more complete understanding of a product’s safety profile, enabling detailed disproportionality reviews, and providing additional validation for routine safety data analysis.

Learn More

• Enablement: Enable Calculations and Statistical Data Creation for FAERS
• Admin Help: Manage Signal Product Profiles
• User Help:
  • Run Signal Calculations
  • Create Statistical Data

Signal Calculations for MedDRA Queries

With this release, Veeva Safety Signal introduces the ability to run Signal Calculations on standard and custom MedDRA queries. This allows a single calculation to analyze multiple MedDRA terms across all hierarchical levels. This feature streamlines signal detection by improving the accuracy of disproportionality analysis and providing a more efficient way to investigate complex signals from the Safety database.

Learn More

• Enablement: Enable Signal Calculations for MedDRA Queries
• Admin Help:
  • Configure Safety Views in Safety Signal
  • Configure Signal Calculation Objects
• User Help:
  • Run Signal Calculations
  • Create Statistical Data

Subgroups for Calculations: Data Model

With this release, Veeva Safety Signal introduces new Subgroup object reference fields and a Subgroup multi-value picklist to the Statistical Data object. These updates lay the foundation for the Subgroups for Calculations feature, which will allow user-defined subgroups to be used for precise signal calculations in a future release.

SafetyDocs

Clearer Error Handling When Generating PSMF PDFs

With this release, Veeva SafetyDocs introduces a clearer error message when a user attempts to run the Generate PSMF PDF action on a PSMF Binder containing a placeholder document of type PSMF Generated Report with missing required fields. 

Learn More

• User Help: Manage PSMF Binders and Logbooks

PSMF Link Annotations

With this release, Veeva SafetyDocs supports link annotations in PSMF documents. When generating a PSMF PDF from a PSMF Binder, Vault resolves link annotations to other locations within the PSMF Binder as intra-document links. This enhancement makes it easier to navigate between core document content and reference data in the annexes, improving usability and reader efficiency.

Learn More

• User Help: Manage PSMF Binders and Logbooks

Convert HTML Markup in Literature Abstracts

With this release, Veeva SafetyDocs converts HTML markup in the Abstract field of Literature Articles imported from external databases to formatted text.

Learn More

• User Help: Manage the Literature Review Process

Product Family Support for PV Agreements

With this release, Veeva SafetyDocs supports the classification of PV Agreements at the Product Family level, enabling more efficient agreement management and improving scalability across product portfolios. Previously, PV Agreements could only be classified at the Product level.

Learn More

• Enablement: Enable PVA Management
• User Help: Manage Pharmacovigilance Agreements

Multi-Agreement Activities

With this release, Veeva SafetyDocs supports creating PVA obligation activities that span multiple PV agreements, simplifying configuration and management of activities required by multiple PVAs. With the introduction of PVA Multi-Agreement Activities, users can easily see all PV Agreements and PVA Obligations linked to a Multi-Agreement Activity, and trigger email distributions to all relevant partner contacts.

Learn More

• Enablement: Enable Multi-Agreement Activities
• User Help: Manage PVA Multi-Agreement Activities

Generate Draft Pharmacovigilance Agreement Documents

With this release, Veeva SafetyDocs introduces the ability for Admins to configure templates for Pharmacovigilance Agreement (PVA) document generation. Admins can create and manage PVA Outline templates composed of outline clauses and subclauses and define the alignment and sequence of clauses to ensure proper ordering in the generated Word Formatted Output Template. This enhancement streamlines PVA generation, improves consistency, and reduces manual effort.

Learn More

• Enablement: Enable Generate Draft Pharmacovigilance Agreement Documents
• Admin Help: Configure PVA Outlines
• User Help: Manage Pharmacovigilance Agreements

Risk Measure Support for EMA GVP Module XVI Revision 3

With this release, Veeva SafetyDocs aligns with the EMA’s updated guidance on the categorization and subcategorization of additional risk minimization measures (aRMMs) by introducing new picklist values to Core Risk Measures and Local Risk Measures in accordance with EMA’s guidance to support GVP Module XVI Revision 3.

Learn More

• User Help: Manage Risk Measures

EU Risk Management Plan Support

Veeva SafetyDocs supports the creation of two types of Core Risk Management Plans (RMPs), offering more flexibility with how RMPs are developed and maintained. A new picklist field makes it simple to label each Core RMP as either Company Core RMP or EU RMP. Both types can coexist as sibling records within the same Product Family, ensuring your data stays organized and easy to navigate. Additionally, Core RMP Versions can be easily copied from one sibling Core RMP to another, simplifying the RMP update process.

Learn More

• Enablement: Enable EU Risk Management Plan Support
• User Help:
  • Manage Risk Management Plans
  • Manage Implementation Strategies

Safety & Safety Workbench

Transmission: Sent & Completed Dates

This feature introduces two new standard fields on Transmission objects: Transmission Sent Date and Transmission Completed Date. This provides a standardized way to capture and track the exact dates of Transmission events, improving visibility into compliance for Submissions, Distributions, and Early Notifications.

Learn More

• Enablement: Enable Transmission Sent & Completed Dates
• User Help:
  • Create an Early Notification Report
  • Create a Submission
  • Create a Distribution

Safety & Safety Signal

Simplified Deletion for Case Products & Adverse Events

With this release, Veeva Safety supports deleting Case Products and Case Adverse Events with a single click. Deletions cascade to associated records and clear references in related records. Previously, users had to manually delete multiple records across various objects, which was time-consuming and error-prone. This enhancement saves time, reduces manual effort, and minimizes the risk of data inconsistencies during Case processing.

Learn More

• User Help: Case Data Entry Overview

Safety Workbench & SafetyDocs

Scheduler Enhancements

This feature introduces several improvements to the Veeva SafetyDocs and Veeva Safety Workbench scheduling capabilities:

• Additional monthly Schedules: Vault introduces standard Schedules for the last day of the month and the first selected day of the week each month, and corresponding Schedule Components for creating custom Schedules.
• Enhanced support for end-of-month scheduling: Monthly scheduling now adjusts to months with fewer days. If a selected day doesn’t exist in a given month (e.g., 29th, 30th, or 31st), Vault schedules the event on that month’s last day and returns to the original scheduled day for the next applicable month. This includes leap year handling for February 29.
• Audit trails: Date changes on scheduled events will now be shown in audit trails.

Learn More

• Enablement:
  • Enable PVA Scheduling
  • Enable Workbench Report Set Scheduling
• Admin Help: Configure Schedule Records
• User Help:
  • Manage Pharmacovigilance Agreements
  • Generate & Run Reports from Workbench Report Sets

Safety, Safety Workbench, SafetyDocs & Safety Signal

Safety Standardization 25R3: Data Model

With this release, Veeva Safety adds several standard components to ensure customers can easily adopt best practices for major business processes. Additional Standardization capabilities will be available in upcoming releases. To align Safety with all other Veeva applications, this release also inactivates all standard layouts so that they can be used only as a reference in Vault. This also eliminates potential clutter in the All Layouts view.

Additionally, this release introduces a Tag field to help organize safety views, and standard Product-Event Dispositions to record signal detection outcomes.

Safety Coding Tab Collection

With this release, Veeva Safety introduces a standard Safety Coding tab collection, allowing Admins to easily view and manage the following coding-related objects from one centralized entry point:

• Dictionaries
• Studies
• Products
• MedDRA
• Watchlists

Although this feature is Auto-on, some components may require additional configuration.

Learn More

• Admin Help:
  • Configuring Tab Collections
  • About Permission Sets
• User Help: Navigate Safety Suite

QualityOne

In addition to the below release notes, the QualityOne Veeva Connect community offers general release communications, release highlights, and key feature demos.

QualityOne

Teams Enhancements

This feature introduces the following enhancements to Teams functionality within QualityOne.

Although this feature is Auto-on, some components require additional configuration.

Teams Bulk Management

This feature enables users to manage team memberships for multiple records from a standard Teams Bulk Management tab. The new functionality supports the ability to add, remove, or replace team members, reducing administrative effort and improving user experience.

Learn more about managing Teams in bulk.

Related Object Security

This feature allows users assigned to a team role on a team-enabled record to automatically gain the same access to related records created by another record owner, such as Action Items, as they have on the main team-enabled record. This prevents administrative issues by ensuring records remain accessible and manageable even if the original record owner leaves the organization or is otherwise replaced on the main team-enabled record.

Learn more about configuring Related Object Security.

Cascade Delete Team Members

This feature simplifies the record deletion process by automatically removing associated team assignments when a team-enabled record is deleted. This eliminates the need for complex processes and Admin-level tools and allows for a clean, one-step deletion of both the record and its team assignments.

Learn more about deleting records with Team assignments.

Related Record Automation: User Object Update

This feature discontinues support for new configurations of Related Record Automation on the User object. With this release, Admins cannot select the User object as the Source Object when creating new Related Record Setups. Existing Related Record Setups and configurations of the Create Related Record action that use the User object are not affected. This change ensures system stability by preventing problematic configuration while allowing existing configurations to continue functioning.

Learn more about Related Record Automation.

Error Message Enhancements

With this release, users now see more user-friendly wording on validation error messages, and impacted fields on the object record are now referred to by their user-facing label values. Prior to this release, validation error messages referenced impacted fields by their API names only rather than their labels (for instance, inspection__v rather than Inspection).

QMS (QualityOne)

5 Whys Analysis: Increased Global Limits

With this release, the limits within the 5 Whys Analysis UI for both the number of Why trees per diagram and the number of Why items per tree increase from ten to 20. These expanded limits provide users with greater flexibility for more exploratory and comprehensive analysis, particularly for complex issues.

Learn more about performing 5 Whys Analysis.

Inspections: Expanded Print Record Support

This feature expands support for Print Record functionality on Inspection records. When users select Download as PDF on Inspection records, the test result and localized data fields within the Inspection Sample Test Result related records grid display the same on the generated PDF as they do in Vault.

Learn more about Inspection Management.

Improved Identification of Header Data in CoA Files

This feature enhances the CoA file analysis process in Vault by enabling Admins to configure additional matching rules to extract key header information, such as the material code, from CoA documents. This allows Vault to extract additional information from CoA files, particularly in situations where a CoA file does not contain a header key field. Additionally, Admins can configure custom logic to use this information to identify the correct Inspection Plan and populate it on the relevant Inspection. This feature streamlines the inspection test result evaluation and decision-making activities.

Learn more about defining COA Matching Rules.

HACCP

Refresh the HACCP Flow Diagram without Resetting View

This feature allows for seamless updates to the data displayed on the HACCP Flow Diagram without disrupting the user’s current focus. When users click the Refresh () icon on the HACCP Flow Diagram, Vault reloads or refreshes the diagram’s content while preserving the user’s zoom level and area of focus. If there are open sections and filters applied on sections within the Information panel, these are also preserved upon refresh. This ensures that users can continue working from where they were before the refresh, minimizing disruptions and enhancing productivity.

Learn more about working with the HACCP Flow Diagram.

QualityOne Client Applications

Sunset QualityOne Mobile Application

This feature retires and removes support for the QualityOne Mobile application, and removes it from Google Play and the Apple App Store. With this release, QualityOne Mobile is no longer available for new installs, and users that have previously downloaded the application should stop using it and uninstall it.

Sunset QualityOne Station Manager

This feature retires and removes support for the QualityOne Station Manager application, and removes it from the Apple App Store. With this release, Station Manager is no longer available for new installs, and users that have previously downloaded the application should stop using it and uninstall it.

QMS (QualityOne) & HSE

Audit Report Printable View: Accessibility Enhancements

This feature introduces accessibility enhancements to the Audit Report Printable View, including Alt Text and additional keyboard shortcuts. These enhancements improve the user experience for users that utilize keyboard navigation and screen readers.

Learn more about working with Audit Report Printable View.

Auditor Profiles & Qualifications: Print Record Support

This feature introduces Print Record support for the Auditor Profiles & Qualifications feature. This enhancement improves the completeness and legibility of the data in downloaded PDFs in cases where object controls are used to display data, images, and special characters.

QMS (QualityOne), HSE, & HACCP

Risk Matrix Visualization: Print Record Support & Permission Handling Enhancements

This feature introduces enhancements to permission handling for the Risk Matrix Visualization that displays in a section on Risk Matrix records. With these enhancements, only users with appropriate permissions can see the visualization. This feature also introduces Print Record support for the Risk Matrix Visualization. When users download a Risk Matrix record to PDF, they can now view the visualization in the downloaded PDF.

Learn more about the permissions required to view the Risk Matrix Visualization.

RegulatoryOne

In addition to the below release notes, the RegulatoryOne Veeva Connect community offers general release communications, release highlights, and key feature demos.

Compliance Management

Formulation Questionnaires: Email Delivery Status

This feature allows users to see whether formulation questionnaire emails have been successfully delivered to supplier contacts.

Learn more about Formulation Questionnaires.

Registration & Dossier Management

Specify Type for Local Impact Assessment Lifecycle Rules

This feature extends the Local Impact Assessment Enhancement: Ignore Cancelled & Withdrawn Objectives functionality delivered in 24R3 so that Registration & Dossier Management users can reuse an approved Registration when conducting a Local Impact Assessment, while avoiding any expired Registrations.

Learn more about Local Impact Assessments.

25R3 Registration & Dossier Management Enhancements

This feature updates the Create Registrations and Objectives action to set the Event field of Registration Objectives and enforces alignment between Registration Type and standard object types.

Learn more about generating requirements.

Compliance Management & Registration & Dossier Management

Display Full Text Values in Viewers

This feature enhances the Requirement Hierarchy Viewer and Registration Item Viewer in Registration & Dossier Management Vaults and the Formulation Composition Viewer in Compliance Management Vaults. Users can now hover over truncated text displayed in the viewers to view the entire value before selecting records.

Learn more about the Requirement Hierarchy Viewer, Registration Item Viewer, and Formulation Composition Viewer.

Veeva Claims

In addition to the below release notes, the Claims Veeva Connect community offers general release communications, release highlights, and key feature demos.

Veeva Claims

Assign Available Claims: Copy Related Records

This feature enables users to copy Local Adaptations and Substantiations to Claims created when assigning available Claims related to a Product when running the Assign Available Claims action, significantly reducing the number of clicks needed to copy existing Local Adaptations and Substantiations.

Learn more about assigning available Claims.

Enhanced Substantiation Document Panel with Supported Local Adaptations

This feature enhances the Substantiation Doc Info panel so users can view and directly access all Local Adaptations supported by the substantiation document.

Learn more about substantiating Claims and Local Adaptations.

Bulk Add Multiple Substantiation

This feature enables users to link multiple Substantiations to Claims in a single operation using the existing Bulk Add Substantiation option after initiating a bulk action on Claim records.

Learn more about substantiating Claims.

Bulk Add Local Adaptation Comment: Permission Handling Enhancement

With this release, users must have read permission for the Claim object to run the Bulk Add Comments record action on Local Adaptations.

Learn more about configuring the Bulk Add Comments action.